Do you have a Software as a Medical Device or maybe you plan to have one? Then listen to this episode with Vivek Thakkar which will provide you some insight on what is SaMD and how to get Certified. If you need more details, please contact us so we can help you.
Who is Vivek Thakkar?
Regulatory affairs professional with a Master’s degree and 12 years of experience with Class II and Class III medical devices. Currently supporting regulatory activities for Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD). Proven success in building and executing global regulatory strategies for interventional cardiovascular products. Skilled at hiring, training, and inspiring regulatory experts for medical device submissions. Passion for simplifying
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…
Links
Vivek Thakkar Linkedin: https://www.linkedin.com/in/vivekbthakkar/

Blog post SaMD: https://easymedicaldevice.com/SaMD

Clinical Evaluation Software: https://www.youtube.com/watch?v=HIycmCuBsi0



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



Certify your Software as a Medical Device with Vivek Thakkar

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.

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Entrepreneurship

 
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/
 
 
 

Medical Device News June 2024 Regulatory Update


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


Summative Evaluation – Common mistakes


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


Are you more Corrections or Corrective Actions or Preventive Actions?


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


How to select and evaluate your Contract Manufacturer?


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


Certify your Software as a Medical Device with Vivek Thakkar

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