Easy Medical Device Podcast

You don’t know what a regulator will say when seeing your AI/ML Software, then listen to this episode. Richie Christian will explain the important elements that you should take care off before to submit your dossier to your Notified Body or your Competent Authority. So enjoy.

Who is Richie Christian?

Richie Christian has more than 10 years of experience in medical device regulatory and quality. He has a Master’s degree in neurophysiology from the University of Auckland, and is passionate about digital transformation of the healthcare industry. Throughout his career, Richie has worked in numerous regulatory and quality roles with not only traditional hardware device manufacturers, but also cutting-edge AI/ML-enabled SaMD manufacturer.

In his most recent role as the Head of Regulatory and Quality, he spearheaded the development and implementation of a streamlined QMS, enabling them to achieve MDSAP certification and secure market authorisations for an innovative orthopaedics AI/ML-enabled SaMD in USA and Japan.

Richie relocated to Basel, Switzerland from New Zealand as a consultant for wega Informatik where he now applies his decade-long experience to help companies develop and deliver compliant medical device software. 

Who is Monir El Azzouzi?

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Links

·      Richie Christian Linkedin Profile: https://www.linkedin.com/in/christianrichie/

·      Wega Website:  https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance

·      AAMI/BS standard https://knowledge.bsigroup.com/products/application-of-iso-14971-to-machine-learning-in-artificial-intelligence-guide?version=standard

·      Good Machine Learning Practice for Medical Device Development: Guiding Principles: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles

·      Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles

Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

■ Twitter:

https://twitter.com/elazzouzim

■ Pinterest: https://www.pinterest.com/easymedicaldevice

■ Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

If you are looking for selling your medical devices in Europe, you will then maybe need a Notified Body unless your product is class I. In this episode, we talk with Thomas Lommatzsch about the process of designation and why it is so difficult. We will also cover some questions regarding the auditors, the costs, the audit by the competent authorities… So stay tuned. 

Who is Thomas Lommatzsch? 

Thomas LOMMATZSCH heads the Medical Business Unit of AFNOR Certification, which deals with the certification of medical devices within the notified body AFNOR Certification (NB0333). With over 20 years' experience within Notified Bodies under various European regulations, he has completed several notification projects, most recently the AFNOR Certification notification project under the MDR. Thomas is also involved in standardization work relating to the application of the AI Act, particularly with its application to medical devices. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

Thomas Lommatzsch Linkedin Profile: https://www.linkedin.com/in/thomas-lommatzsch/ 

AFNOR webpage: https://certification.afnor.org/qualite/marquage-ce-dispositifs-medicaux 

EU MDR 2017/745: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20230320 

EU IVDR 2017/746: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20230320 

French competent authority ANSM: https://ansm.sante.fr/ 

JAT Joint Assessment: https://health.ec.europa.eu/document/download/b9d671f5-02d0-44b1-a207-b07aeb4ef931_en?filename=md_info_ja_mdr_en.pdf 

MDCG 2022-13 Designation, re-assessment and notification of conformity assessment  

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers. 

Who is Heena Thakkar? 

Heena Thakkar is a regulatory consultant currently working with Alceon Medtech Consulting. She is based in Gujarat, India. Heena is qualified in risk management, design controls, usability engineering, clinical evaluation, clinical trial management, quality management systems and process validation. She is also a certified internal auditor.  

Heena has around 8 years of experience in the field of regulatory affairs and quality management system for medical devices. She is experienced in regulatory submissions for vast range of devices ranging from orthopaedic devices, endovascular devices, single-use consumables, ophthalmic devices and wound care devices. She also conducts external trainings in the areas such as risk management, quality management system, EU MDR and EU IVDR.  

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

Heena Thakkar Linkedin Profile:  

https://www.linkedin.com/in/heenathakkar?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_appAlceon Medtech Consulting Website:  

https://alceonconsulting.com

List of standards helpful for cleaning validation of reusable instruments  

ANSI/ AAMI ST98: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices https://www.aami.org/standards/featured-standards/aami-st98  

USFDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (https://www.fda.gov/media/80265/download) 

ISO 17664-1:2021: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (https://www.iso.org/standard/81720.html) 

ISO 15883-1:2006: Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (https://www.iso.org/standard/41076.html) 

ISO 15883-5:2021: Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (https://www.iso.org/standard/68297.html) 

ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3208-20.html) 

ASTM F3293-18: Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3293-18.html) 

There are many additional standards that manufacturers will need to refer to in addition to the ones listed above. Contact us at [email protected] for additional information or service inquiry. Thank you!  

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

EUROPEEU MDR 26 May 2024 - Was there any apocalypse:

France: https://ansm.sante.fr/actualites/reglement-europeen-relatif-aux-dispositifs-medicaux-fin-de-la-periode-de-transition

Netherland: https://www.igj.nl/zorgsectoren/medische-technologie/nieuws/2024/05/23/fabrikanten-van-medische-hulpmiddelen-moeten-uiterlijk-26-mei-een-aanvraag-hebben-ingediend-voor-ce-certificering

EU shortage managed - EUDAMED and IVD extension also discussed: https://www.consilium.europa.eu/en/press/press-releases/2024/05/30/medical-devices-council-adopts-new-measures-to-help-prevent-shortages/?utm_source=brevo&utm_campaign=AUTOMATED%20-%20Alert%20-%20Newsletter&utm_medium=email&utm_id=320

EMA Q&A on Combination products - Do you need a Notified Body? https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf

EU talks about SoHo -: Substances of Human Origin

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:PE_8_2024_INIT&qid=1716536451356

https://www.consilium.europa.eu/en/press/press-releases/2024/05/27/council-adopts-new-rules-on-substances-of-human-origin/

Italy Database error - Updating expired (AI)MDD certificates https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6569

Ireland guide on In-House IVDs - Laboratories to listen: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-for-health-institutions-who-manufacture-and-use-in-house-ivds-in-ireland-v1.pdf?sfvrsn=8

Combined Studies in the EU - COMBINE PROJECT:

https://ec.europa.eu/newsroom/sante/items/830485/en

https://health.ec.europa.eu/document/download/77e1409a-f4c0-45db-bff1-4873c7a0e7ae_en?filename=md_combined-analysis-phase-report.pdf

Notified Bodies

Survey Result: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf

Team-NB Survey: https://www.team-nb.org/wp-content/uploads/2024/05/Team-NB-MD-Sector-Survey-PressRelease-20240515.pdf

New Notified Bodies for EU MDR –

MTIC InterCert Italy: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43390&filter=notificationStatusId:1

Kiwa Istanbul: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007731?organizationVersion=18

QMS Services GmbH Austria: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1007832?organizationVersion=1

UKUK on international recognition - Approve products without CE or UKCA mark: 

https://www.gov.uk/government/news/mhra-announces-a-proposed-framework-for-international-recognition-of-medical-devices

https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices

UK implementation of Future Regulation - When will this come in force: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations

UK Common Specifications for IVD - Provide your opinion: https://www.gov.uk/government/consultations/common-specification-requirements-for-in-vitro-diagnostic-devices

UK suspected counterfeit Medical Device -  How to report: https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device

UK Ai Airlock - Be ready to help the government: https://www.gov.uk/government/news/mhra-launches-ai-airlock-to-address-challenges-for-regulating-medical-devices-that-use-artificial-intelligence

Webinar planned July 23rd: https://www.eventbrite.co.uk/e/ai-airlock-the-regulatory-sandbox-for-aiamd-in-healthcare-webinar-tickets-896407919217

Easy Medical Device: eQMS SmartEye

Video: One of the best eQMS for Medical Devices  One of the best eQMS for Medical Devices

Events:Medtech Conf:

Title: International Medical Device Exhibition and Conference - Subtitle: Malaysia 10th to 12th December 2024 : https://medtechconf.com/event/imdec-2024-exhibition-conference/

Training

Green Belt Training for EU MDR 2017/745 24th-28th June 2024: https://school.easymedicaldevice.com/gb/

EU Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/

Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/

WORLDUSUS Remanufacturing or Servicing  - Webinar replay included:

https://www.fda.gov/media/150141/download

Webinar: https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-guidance-remanufacturing-medical-devices-06272024

US - Use of Patient Generated Data - Medical Device Development: https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case

US Laboratory Developed Tests - Final rules defined and Webinar to explain:

https://www.fda.gov/medical-devices/medical-devices-news-and-events/webinar-final-rule-medical-devices-laboratory-developed-tests-05142024

https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-frequently-asked-questions

https://www.fda.gov/news-events/press-announcements/fda-takes-action-aimed-helping-ensure-safety-and-effectiveness-laboratory-developed-tests

Australia

Australia - in-house IVDs requirements - Support Australian Laboratories: https://www.tga.gov.au/resources/resource/guidance/regulatory-requirements-house-ivds

Australia on boundary and Combination products List: https://www.tga.gov.au/sites/default/files/2024-05/examples-boundary-combination-products-and-product-category.pdf

Saudi Arabia

Saudi Arabia - Webinar Biological Evaluation - 6 June 2024 10am Saudi Time https://www.sfda.gov.sa/en/workshop/716404

NigeriaGuidance to register Medical Devices - Registration, labelling and advertising:

https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Registration-Regulations-2024.pdf

https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Labelling-Regulations-2024.pdf

https://nafdac.gov.ng/wp-content/uploads/Files/Resources/Regulations/Draft_Regulations_2024/Medical-Devices-and-Related-Products-Advertisement-Regulations-2024.pdf

India

CDSCO laboratory testing - But in the Country and not outside: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg=

Malaysia

Malaysia Guidance for Medical Device - Change Notification support: https://www.mda.gov.my/index.php/announcement/1401-public-comment-draft-guidance-document-change-notification-for-registered-medical-device

Hong-Kong

Overview of a Local Responsible Person - Who? What? When? Where?: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf

Singapore

 Singapore Cybersecurity labelling- SAt which level is your product: https://www.csa.gov.sg/our-programmes/certification-and-labelling-schemes/cls-md

PODCASTPodcast Nostalgia - What topics were discussed

Episode 283: Quality Field Service for Medical Devices with Michael Israel: https://podcast.easymedicaldevice.com/283-2/

Episode 284: How to select and evaluate your Contract Manufacturer with Keith Smith: https://podcast.easymedicaldevice.com/284-2/

Episode 285: Are you Correction or Corrective Action or Preventive Action with Vincent Cafiso: https://podcast.easymedicaldevice.com/285-2/

Episode 286: Summative Evaluation - Common Mistakes with Amandine Broussier: https://podcast.easymedicaldevice.com/286-2/

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

I am sure that when we talk about usability, you are not really sure what should be done. Usually we are also following a standard for that which is IEC 62366. On this episode, Amandine Broussier will specifically focus on one part of usability which is the Summative Evaluation. She will explain what this is and when it should be done. So listen to this to be an expert in Usability. 

Who is Amandine Broussier ?

Amandine Broussier is an independent medical devices usability specialist who supports medical device manufacturers in their usability engineering process (EN 62366-1:2015). She has 8 years of experience in the usability engineering, working with around 30 manufacturers on different devices (hardware, software) (class II, class III and IVD). 

Amandine can help you through all stages of the usability engineering process including auditing your current usability documentation with recommendations for improvement, identifying of use-related risks, writing the different documents required by the EN 62366-1 standard, and carrying out your formative and summative evaluations for CE marking and FDA approval. She also provides introductions to usability engineering for companies to help them understand the expectation of notified bodies with regards to usability standards.  

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link 

Amandine Broussier Linkedin Profile: https://www.linkedin.com/in/amandine-broussier-888a41113/ 

IEC 62366-1 link: https://www.iso.org/fr/standard/63179.html 

IEC 62366-1/A1 link: https://www.iso.org/fr/standard/73007.html 

IEC 62366-2: https://www.iso.org/fr/standard/69126.html 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Do you have to manage complaints, CAPA, Non-conformances, audits, management reviews… for your company. Then you need to put in place actions. Today we will explain to you with Vincent Cafiso what are Correction, Corrective Actions and Preventive Actions. 

Who is Vincent Cafiso ? 

Named as one of MD+DI's 24 Medtech Voices to Follow in 2024, Vincent Cafiso is a former U.S. FDA Investigator with 30-years of medical device and in vitro diagnostics (IVD) industry experience and is currently the Founder and Managing Consultant for his firm Practical Compliance Results. Vincent prepares his clients to be ready for their next FDA inspection and Notified Body audit consulting in the areas of compliance, quality assurance, and quality systems. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link: 

Vincent Cafiso Linkedin Profile: https://www.linkedin.com/in/vincentcafiso/ 

CREO Consulting Website: https://creoconsulting.com/ 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Medical Device manufacturers can also involve third party companies to manufacture their devices. We call them Contract Manufacturers. But they are only your supplier and not the legal manufacturer of the product. So now the question is how to select them and also how to handle them. Let’s find that out with Keith Smith from Vonco 

Who is Keith Smith? 

Keith Smith is the President and CEO of Vonco Products. Keith has a passion for cultivating infectious energy, innovation, and creation. He generously contributes time and resources to entrepreneurial, education, athletic, and health endeavors. Prior to acquiring Vonco in December of 2012, he served as a General Manager of Carbonless Rolls and Security Papers for Appleton Papers, the largest division of a $1BN paper company. Keith holds a bachelor’s degree in industrial engineering as well as an MBA from Northern Illinois University and Lean and Six Sigma certifications from the University of Michigan.  

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link 

Keith Smith Linkedin Profile: https://www.linkedin.com/in/keith-smith-725508b/  

Keith Smith Website: https://keithsmith.io/  

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Michael Israel from Zuper.co is helping us understand the world of Field Service and then we can understand better how some information collected by Field Service Engineer can help Quality Department to have a better operation. Collect machine performance, train technicians, identify issues.  

Michael will also talk about Zuper which is a FSM software (Field Service Management) and can help you save time and collect the write information. So don’t hesitate to check his website. 

Who is Michael Israel? 

Michael Israel is Vice President of Community and a member of the executive leadership team at Zuper. Michael has worked in customer and field service for more than 40 years. He spent 20 years in his early career managing both domestic and international field service operations, including 12 years with IBM’s Field Engineering organization. Over the past three decades, he has held management and executive roles with major providers of CRM and Field Service software applications, including tenures with IFS, Oracle, and SAP.   

His broad experience includes marketing, selling, supporting, and implementing CRM and Field Service software applications. Michael also served as a Field Service analyst for Aberdeen Group, the Technology Services Industry Association (TSIA), Jolt Consulting, and the Service Council. 

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

Michael Israel Linkedin Profile: https://www.linkedin.com/in/michaelisrael1/ 

Zuper Website: https://zuper.co 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

EU

Notified Bodies

TUV SUD Denmark under MDR –Welcome to the Brother or Sister: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=150a0abbc0d4397086d648963fc940a321e02c11&group=NOTIFICATION&download=true

AFNOR 46th NB under MDR –Finally a second one for France: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications?organizationRefeCd=EPOS_43655&filter=notificationStatusId:1

MDCG 2024-4 Guidance–Safety reporting in Performance Studies or IVD: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf

Form: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F54cbbfd4-5808-4560-93ef-017f2a3b0f41_en%3Ffilename%3Dmdcg_2024-4_appendix_en.xlsm&wdOrigin=BROWSELINK

MDCG 2024-5 Guidance – SInvestigator's Brochure for Clinical Investigation: https://health.ec.europa.eu/document/download/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf

Checklist 2024-5 https://health.ec.europa.eu/document/download/a387e3e7-65e3-4af5-bb98-2281949feded_en?filename=mdcg_2024-5-appendix-a_en.docx

 Survey Article 17 – Reprocessing of single use devices: https://op.europa.eu/o/opportal-service/download-handler?identifier=35ea0c60-e82c-11ee-9ea8-01aa75ed71a1&format=pdf&language=en&productionSystem=cellar&part=

 Team-NB: ESMINT initiative –  Call for expert: https://www.team-nb.org/esmint-initiative/

 Spain AEMPS Bulletin on Health Products –  From Jan - March 2024: https://www.aemps.gob.es/informa/boletin-sobre-productos-sanitarios-enero-marzo-de-2024/#vigProdSan

 Germany: Classification - Bfarm to help you classify your device: https://www.bfarm.de/DE/Medizinprodukte/Antraege-und-Meldungen/Antrag-auf-Klassifizierung/_artikel.html

 Swiss: SaMD –  information sheet to help Software companies: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_007d_mbmedizinprodukte-software.pdf.download.pdf/BW630_30_007e_MB%20Medical%20Device%20Software.pdf

Turkey: 26 May 2024 –  Reminder of the May 26th, 2024 deadline for EU MDR https://titck.gov.tr/duyuru/imalatcisi-tarafindan-sure-uzatimindan-faydalanmayacak-urunlerin-uts-surecleri-24042024160706

Article to read

European Medical Writers Association – Focus on Translation: https://journal.emwa.org/media/5111/mew-331-final.pdf

Training

Training EU MDR –  Green Belt Certification Program GB31 May 2024: https://school.easymedicaldevice.com/course/gb31/

 Malaysia training –  Calendar 2024: https://portal.mda.gov.my/index.php/doclink/mda-core-training-list-2024-latest-nur-izzati-adha-binti-zuman-mda-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJtZGEtY29yZS10cmFpbmluZy1saXN0LTIwMjQtbGF0ZXN0LW51ci1penphdGktYWRoYS1iaW50aS16dW1hbi1tZGEtcGRmIiwiaWF0IjoxNzE0MDEwNjUyLCJleHAiOjE3MTQwOTcwNTJ9.1KCY_1RCNi1mnJSCP30llN8kaBvcBJU6G_JMpc-OttI

Team-NB training  -  IVDR technical Documentation July 3rd, 2024: https://www.team-nb.org/fourth-session-ivdr-technical-documentation-training-for-manufacturers/

Events

 Events –  Check Medtech Conf: https://MedtechConf.com

Rest of the world

 South Korea: Certificate Check –Verifying authenticity of certificates issued by MDFS: https://emedi.mfds.go.kr/msismext/emd/uif/issuDocTruflsEngView.do

 South Korea: IVD method –How to register IVD in South Korea: https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%B2%B4%EC%99%B8%EC%A7%84%EB%8B%A8%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95/(19695,20230816)

 South Korea: UDI rules to follow –Same but not the same: https://www.mfds.go.kr/eng/brd/m_40/down.do?brd_id=eng0011&seq=72636&data_tp=A&file_seq=1

 Mexico: Draft Mexican official standard –Labelling of Medical Devices: https://www.dof.gob.mx/nota_detalle.php?codigo=5724246&fecha=23/04/2024#gsc.tab=0

 Australia: Consultation on IFU –  Call for more flexibility: https://www.tga.gov.au/resources/consultation/consultation-availability-instructions-use-ifu-more-flexible-formats

Podcast

 Radiation Sterilisation Master File   -  Adam Issacs Rae: https://podcast.easymedicaldevice.com/279-2/

 What is the impact of AI Act on Medical Devices –  Erik Vollebregt: https://podcast.easymedicaldevice.com/280-2/

 Why and how to build your Quality Culture – Lesley Worthington: https://podcast.easymedicaldevice.com/281-2/

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

A quality culture seem to be a nice to have. But after listening this podcast episode with Lesley Worthington, you will see that it is worth to build one. We will review the description of a quality culture and how to build it. But also if this is required by a regulation and how you can align it with your compliance duties. Check this and share it with your team. 

Who is Lesley Worthington? 

Lesley works with individuals and teams to fine-tune their Quality conversations, initiatives, and internal communications to create a better understanding of the role and concepts of quality assurance throughout their organization. 

Through her leadership and executive coaching, she supports professionals as they work on improving their relationships and effectiveness in their roles allowing them to achieve their fullest potential, professionally, and empowering them to move their organizations toward a robust Quality Culture. 

She runs a community, The Quality Network, which supports Quality professionals as they work on the skills that allow them to build a Quality Culture. The Quality Network is a place for learning, coaching, support, and networking and includes webinars, resources, a member platform, courses, and office hours.  

She combines 20 years of quality and regulatory experience in medical devices, in Canada, with thousands of hours of teaching and coaching to provide her clients with the skills, techniques, insights, and mindset that raise their confidence, take their communication skills to the next level, and allow them to have a positive impact in their organizations. 

She’s got a Psychology Degree, a Law Degree, English as a Second Language Teaching Qualifications, and is a Certified Executive Coach. 

Who is Monir El Azzouzi? 

Monir El Azzouzi, a distinguished expert in the medical device sector, holds a Biomedical Engineering degree from ISIFC in France. With extensive experience at top-tier companies such as Bausch+Lomb, Aesculap, and Johnson & Johnson, Monir has a deep understanding of the industry’s challenges and opportunities. His commitment to enhancing industry standards and support led him to establish Easy Medical Device. 

Easy Medical Device is an innovative company dedicated to enriching the medical device community through educational outreach such as podcasting, blogging, and video creation. The company also offers specialized training programs, notably the Green Belt Certificate for EU MDR, to elevate professional skills within the industry. 

Beyond education, Easy Medical Device provides comprehensive consulting services, helping manufacturers navigate the complexities of CE Marking, FDA registration, clinical evaluation reports, internal audits, design and development, supplier reviews, eQMS implementation, and due diligence. Our expertise extends to acting as authorized representatives and importers in Europe, Switzerland, and the UK, facilitating smoother market entry for our clients. 

Monir's vision for Easy Medical Device is to establish it as the definitive one-stop shop for all services related to medical device manufacturers. We are committed to assisting you in introducing and advancing your projects with efficiency and compliance. 

Do not hesitate to contact Monir El Azzouzi at Easy Medical Device to explore how we can support your medical device initiatives. 

Links

LinkedIn: https://www.linkedin.com/in/lesleyworthington/ 

Website: https://lesleyworthington.com/  

Email: [email protected]  

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.