Easy Medical Device Podcast

Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what are we talking about. This episode will help you understand AI and also understand what the risks to it are. This is really an interesting topic, but a lot of people are really afraid when we talk about AI. We will try to give you some tips to clarify the situation. 

For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies who use Artificial Intelligence for their software. 

Who is Christophe Girardey? 

Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. 

Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance. 

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: 

Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/

Wega Website : https://www.wega-it.com/ 

Medical Device Compliance: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance 

Data Sciences: https://www.wega-it.com/clinical-development-it#data-science 

Wega Breakfast: Artificial Intelligence in GxP environments: https://www.youtube.com/watch?v=dCDwEkXd9jU&t=11s 

Nature Article (co-authored): 

https://www.nature.com/articles/s41582-020-00448-7FDA list of Software with AI: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices?

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

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

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

Have you ever been to an audit and the auditor is asking you to show them the validation of your Quality Management System software. The first reflex is to say “But I buy it like that so I don’t validate that” and the auditor to say “Ok, then there is a non-conformity to ISO 13485”. I know painful. So let’s review today the way to validate you Quality tools and why this seem so important. For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies to validate their software.

Who is Christophe Girardey?

Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.

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 from the Video

Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/
Wega Website : https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance https://www.wega-it.com/computer-systems-validation-quality-assurance

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.

I am sure that at a certain point, your company will try to market your medical devices in Saudi Arabia. And now you are looking for the information that will help you to accelerate the registration of the products. In this episode, Ahmed Hendawy from Registitute will help us understand the best strategy to do that. He will explain to us also the similarities between SFDA and EU MDR. So if you are really motivated to register your product within SFDA then this is the right podcast episode for you. 

Who is Ahmed Hendawy? 

Ahmed is an esteemed leader in the field of healthcare consulting, renowned for his deep expertise in healthcare regulations, market access, and business strategy within the MENA region. As the founder and driving force behind Registitute, Ahmed has established the firm as a premier provider of specialized services in regulatory affairs and market access. 
With a distinguished career, including a previous role as the Head of Regulatory Affairs for the MENA region, Ahmed has demonstrated exceptional skill in navigating complex regulations and spearheading successful market entry strategies. Under his visionary guidance, Registitute has garnered a reputation for excellence and innovation in the healthcare consulting landscape. 
Registitute stands apart by delivering tailored solutions that address the unique challenges faced by healthcare organizations operating in the MENA region. Ahmed's strategic vision, combined with the expertise of the Registitute team, continues to drive positive change and support healthcare organizations in adapting to the ever-evolving healthcare landscape in the MENA region. 
In summary, Ahmed's leadership and Registitute's unwavering commitment to providing exceptional services position them as a trusted partner for healthcare organizations seeking regulatory expertise and market access support in the MENA region. 

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: 

Ahmed Hendawy Linkedin :  https://www.linkedin.com/in/ahmed-hendawy-a0a81511a 

Registitute LinkedIn: https://www.linkedin.com/company/registitute/  

Registitute Website : www.registitute.com  

AL TIRYAQ LinkedIn : https://www.linkedin.com/company/al-tiryaq/  

SFDA website : www.sfda.gov.sa  

SFDA Guidance for Medical Device registration: https://sfda.gov.sa/sites/default/files/2019-12/MDS-G5_1.pdf  

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

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

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

Sponsor Medboard https://www.medboard.com/

EU

Annex XVI transition

EU MDR Domino is making more falls. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194New Timeline

Until 31 December 2029

Cybersecurity and privacy in AI

Medical imaging diagnosis https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosisANSM wants barcode on Field Safety Notice

Why not all the other countries

https://ansm.sante.fr/actualites/lansm-demande-aux-fabricants-de-dispositifs-medicaux-qui-envoient-un-avis-de-securite-dy-apposer-le-code-barres-des-dispositifs-concernes

AEMPS clinical trials involving drugs and medical devices

What are the rules if your device is not CE marked

https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-procedimiento-a-seguir-en-los-ensayos-clinicos-que-impliquen-medicamentos-y-productos-sanitarios/

Switzerland

Medicinal products with a medical device component

rules for combination products

https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/am-mit-mepkomponente-uebergangsbestimmungen.html

UK

Implementation of the Future Regulations

Should you focus on UKCA?

https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations

eQMS

Do you need an eQMS?

Let me introduce Smarteye: https://smart-eye.io

So contact [email protected] to get a demo

USA

Premarket notification for Software

What is different with Premarket submission for hardware

https://www.fda.gov/media/153781/download

Webinar - Final Guidance: Content of Premarket Submissions for Device Software Functions  https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023

Australia

TGA Use of market authorisation evidence

Comparable overseas regulators https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds

Malaysia

Malaysia rules on EU MDR extension

Letter needed

https://www.mda.gov.my/announcement/1224-announcement-mda-approach-on-expired-ec-certificate-for-new-registration-and-re-registration-of-medical-device.html

Saudi Arabia

Saudi Arabia Webinars

AI and Classification are on the spotlightArtificial Intelligence and Software Based on Medical Device https://www.sfda.gov.sa/en/workshop/88535

Introducing the Rules for Classifying the Risk of Medical Devices https://www.sfda.gov.sa/en/workshop/88536

Authorized Representative

Do you need an Authorized Representative

[email protected]

Service: easymedicaldevice.com

Podcast Nostalgia:

Podcast Nostalgia

What was presented in June.

The great Misunderstanding with Florian Tolkmitt: https://podcast.easymedicaldevice.com/236-2/

How to connect Software dev and QARA team with Christophe Girargey Wega: https://podcast.easymedicaldevice.com/237-2/

What should you know on the UKCA extension with Alex Denoon: https://podcast.easymedicaldevice.com/238-2/

Easy Medical Device Support

Thanks for your support

[email protected]

If you need us to perform your own Regulatory Update, don't hesitate to contact us at [email protected]

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, particuarly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

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

Since Brexit happened, there are multiple waves of changes in the UK. First the UK Responsible Person (which is a hybrid of the EU AR and the EU Importer), then the UKCA requirements, then the new legislation consultation (which will largely harmonise UK law with the MDR and IVDR) and now the extension of the unilateral recognition of CE Marks to allow manufacturers more time to obtain a UKCA marks.  

But what all this means for medical devices manufacturers that are already selling in the UK or that plan to sell to the UK. We will review that with Alex Denoon, partner at Bristows. 

Don’t forget to check the links below for more details. 

Who is Alex Denoon? 

Alex advises about Life Sciences regulatory issues all day every day and has been doing so for 30 years. 

He enjoys working with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals, medical devices and IVDs.  Alex has been involved in the development of a number of regulatory frameworks and guidelines. Legal 500 describes Alex as “a straight-talking, commercially astute technology specialist who is always willing to take a view” and who delivers “out-of-the-box solutions”. 

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: 

Alex Denoon Linkedin : https://www.linkedin.com/in/alexdenoon 

Bristows law firm linkedin page: https://www.linkedin.com/company/bristows/ 

Bristows Website : https://www.bristows.com/ 

Bristows Blog post on UKCA: https://www.bristows.com/news/will-we-ever-see-a-ukca-mark-for-medical-devices/#:~:text=Currently%2C%20the%20UK's%20medical%20device,conformity%20marking%2C%20the%20UKCA%20mark 

UKCA future implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations 

Infographics timeline: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1164062/Infographic_-_Devices_transition_timeline.pdf 

How to register a Medical Device in the UK: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk 

Your UK Responsible Person: https://easymedicaldevice.com/uk-responsible-person/ 

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.

Software development is really increasing in the Medical Device world and it is maybe important now to discuss about potential gaps that exist between the Software Development team and the Quality and Regulatory Affairs team. Dev team think that they have too much documents to create and quality thinks that the document that the dev team is creating is not really answering the requirements. So how to solve that. 

Christophe Girardey from Wega who is dealing with that will tell us why we have this situation and also provide some hints on how this can be resolved. 

Who is Christophe Girardey? 

Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. 

Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance. 

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: 

Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ 

Wega Website :  https://www.wega-it.com/ 

Medical Device: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance 

Agile : https://www.wega-it.com/computer-systems-validation-quality-assurance#agility-in-gxp 

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.

Since March 2023 an extension for EU MDR and IVDR was voted by the EU Commission. This podcast episode will remind you the latest news and also answer some frequently asked questions from people. As you may see on the title there are some great misunderstandings, and the objective of today is to clear that out.  

For that I have with me Florian Tolkmitt from Pro-Liance and we will try to give you the best content on EU MDR extension. 

Who is Florian Tolkmitt? 

Florian Tolkmitt is co-founder and CEO of PRO-LIANCE, a consultancy supporting medical device manufacturers with regulatory affairs, clinical affairs and quality management. PRO-LIANCE is based in Germany and serves customers. Florians favorite topics include clinical evaluation, post-market surveillance and risk management and he is also assistant professor at the University of Applied Sciences in Luebeck, Germany, where he teaches Clinical Evaluation to Master students. Apart from that he is the chair of the Regulatory Affairs Professionals Society Chapter in Germany and loves to network and bring the Regulatory Affairs and Quality Community closer together. Last but not least, Florian has a strong interest in Digitalization and is a founding member of the Medical Device Knowledge Unit initiative, that works on an open-source data model for Technical Documentation.  

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: 

EU MDR extension: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf 

Team NB Notified Body confirmation letter: https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-NB-ConfirmationLetterEU2023-607-20230503.docx 

Florian Tolkmitt Linkedin : https://www.linkedin.com/in/floriantolkmitt/ 

Pro-Liance company Site: https://pro-liance.com/ 

EU 2023/607: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607 Podcast episode EU extension with Erik Vollebregt: https://podcast.easymedicaldevice.com/211-2/ 

LinkedIn Company: https://www.linkedin.com/company/pro-liance/

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.

Sponsor MedBoard: www.medboard.com 

EUROPE 

Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf 

EU MDR and IVDR consolidated versions 

EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320 

EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320 

Confirmation letter: 

EU Commission: https://health.ec.europa.eu/latest-updates/template-nb-confirmation-letter-framework-regulation-eu-2023607-2023-05-24_en

MDCG 2020-3 Significant changes: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en 

Update Annex XVI timeline: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=PI_COM:Ares(2023)3232054 

EMDN maintenance project launched: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6262 

Spain: AEMPS and CNCps recognize the need to demonstrate to third parties the validity of expired certificates: https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-nuevo-procedimiento-del-cncps-para-confirmar-la-validez-de-los-certificados-emitidos-conforme-a-mdd/ 

Finland: RoHS is also applicable to Medical Devices: https://www.fimea.fi/web/en/-/rohs-act-also-concerns-medical-devices

Training: 

Green Belt Certification Program June 26th until June 30th. https://school.easymedicaldevice.com/course/gb26 

Switzerland 

Incident reporting 

Incident report for economic operators: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009e_WL%20Incident%20economic%20operators.pdf 

Incident report for users: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_008d_wl-vorkommnismeldung-anwender.pdf.download.pdf/MU680_20_008e_WL%20incident%20report%20user.pdf

Designation of a Vigilance contact person for hospitals: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_10_007d_wl-vigilance-kontaktperson-medizinprodukte.pdf.download.pdf/MU680_10_007e_WL%20Vigilance%20contact%20person%20for%20medical%20devices.pdf

United Kingdom 

New tutorial videos MHRA "How to register medical devices": https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market 

New Regulatory Pathway IDAP: https://www.gov.uk/government/news/new-regulatory-pathway-set-to-support-safe-patient-access-to-innovative-medical-technologies

Assistive Technology: https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use/assistive-technology-definition-and-safe-use 

Report Adverse incidents for Software: https://www.gov.uk/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system/guidance-for-manufacturers-on-reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system 

ROW 

Australia: Guidance on applying the Advertising Code rules: https://www.tga.gov.au/how-we-regulate/advertising/how-advertise/advertising-guidance/resources/resource/guidance/guidance-applying-advertising-code-rules 

Canada: Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations:  https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-proposed-amendments-medical-devices-food-drug-regulations.html India: CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device        :  https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/

Egypt: European Parliament Decision of March 2023 regarding the transitional grace periods granted in relation to the application of MDR&IVDR rules and procedures: https://www.edaegypt.gov.eg/ar/%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2-%D8%A7%D9%84%D8%A7%D8%B9%D9%84%D8%A7%D9%85%D9%89/%D8%A7%D9%84%D8%A5%D8%B9%D9%84%D8%A7%D9%86%D8%A7%D8%AA/%D9%82%D8%B1%D8%A7%D8%B1-%D8%A7%D9%84%D8%A8%D8%B1%D9%84%D9%85%D8%A7%D9%86-%D8%A7%D9%84%D8%A3%D9%88%D8%B1%D9%88%D8%A8%D9%8A-%D8%A7%D9%84%D8%B5%D8%A7%D8%AF%D8%B1-%D9%81%D9%89-%D9%85%D8%A7%D8%B1%D8%B3-2023-%D8%A7%D9%84%D8%AE%D8%A7%D8%B5-%D8%A8%D8%A7%D9%84%D9%85%D9%87%D9%84-%D8%A7%D9%84%D8%A5%D9%86%D8%AA%D9%82%D8%A7%D9%84%D9%8A%D8%A9-%D8%A7%D9%84%D9%85%D9%85%D9%86%D9%88%D8%AD%D8%A9-%D8%A8%D8%AE%D8%B5%D9%88%D8%B5-%D8%AA%D8%B7%D8%A8%D9%8A%D9%82-%D9%82%D9%88%D8%A7%D8%B9%D8%AF-%D9%88%D8%A5%D8%AC%D8%B1%D8%A7%D8%A1%D8%A7%D8%AA-mdr-ivdr/ 

Saudi Arabia Webinar:  

Explain The Essential Principles of Safety and Performance for Medical Devices:  https://www.sfda.gov.sa/en/workshop/88451 Risk Management for Medical Devices: ISO 14971 Requirements https://www.sfda.gov.sa/en/workshop/88450 

Podcast 

Podcast 231: The truth about the UK vs EU situation with Claire Dyson: https://podcast.easymedicaldevice.com/231-2/ 

Podcast 232: Technical File inconsistencies identified by Notified Bodies with Adam Rae: https://podcast.easymedicaldevice.com/232-2/ 

Podcast 233: What if your Medical Device company goes bankrupt with Karandeep Badwal: https://podcast.easymedicaldevice.com/233-2/ 

Podcast 234: How to master Regulatory Intelligence with Ivan Perez Chamorro: https://podcast.easymedicaldevice.com/234-2/ 

Ask Easy Medical Device . We can help you

Contact at [email protected]

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, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

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

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/

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We all need to keep ourselves up to date. But how to access reliable information and how often should a check be done. This is what we will discuss with Ivan Perez Chamorro from MedBoard. You will get some hints on how to optimize your search. 

Regulatory intelligence seems to be a big scary word that people may think it needs a ton of experts to be able to master it. But with digitalization this needs less efforts now. When before you needed to check a lot of journals or visit a lot of country websites, now there are tools that helps you do it quicker. This is mainly the topic of our discussion with Ivan Perez Chamorro from MedBoard.  

Who is Ivan Perez Chamorro? 

Ivan Perez Chamorro is CEO and Founder of MedBoard, a technology company that organises medical technology information and data, makes it fast accessible to manufacturers and key stakeholders, and it is integrated with breakthrough tools as the Vigilance automation. MedBoard is made up of leading engineers, scientist and medical professionals. This big data platform covers from Regulatory, to Clinical, Market and Technical. Ivan has both strong science and business background, he holds a degree and MSc in Physics from Universidad de Salamanca, and an MBA from IE Business School. Ivan is very active in medical device industry, and he is also part of the TOPRA MedTech SPIN. After having a chronic sports injury while playing basketball, and spending many years in rehabilitation, he decided after physics graduation to work in the medical devices industry. Ivan has lived in different countries and likes travelling, painting, and adventure sports, and has special interest in innovation, entrepreneurship, and technology. MedBoard is not the first project, and Ivan has have a number of entrepreneurship projects in the past, in the medical and outside of medical devices industry. Before Medboard, Ivan had worked for many years within the industry, as an employee of leading medical companies and as a consultant in the areas of product and business development, regulations, and strategy, from operational roles to advising technical and top management. He has broad experience with different types and classes of medical devices and combination products, supporting a variety of organization models, from start-ups to large corporations.

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: 

Ivan Perez Chamorro LinkedIn: https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22/

Blog post Medboard: 

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.