Easy Medical Device Podcast

The EU MDR is requiring more transparency and for the PMS has a lot to play on it. In this episode we will explain to you a difference that is visible for PMS which is the Proactive Postmarketing Surveillance. We will explain what they mean by that and how some digital tools can help you.

► Who is Marcus Emne?

Marcus Emne is the CEO & founder of Hoodin, the intelligence SaaS for life science & compliance. Marcus has extensive experience in international business from both high tech, software and life sciences. Over the last years, he has had a focus on intelligence and the subdomains Ai, Automation and Machine Learning in relation to regulatory needs within life science. If you wish to get further guidance or discuss RA/QA in relation to Ai, Automations and Machine Learning, feel free to contact Marcus. 

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► 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.

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► Links from the Video

■Schedule a discovery call: https://rb.gy/nl9ghd

■email: [email protected]

■LinkedIn: https://www.linkedin.com/in/marcusemne/

■LinkedIn profile Marcus Emne: https://www.linkedin.com/in/marcusemne/

■Hoodin web page: https://www.hoodin.com/

■Schedule a discovery call: https://rb.gy/nl9ghd

■MDCG PMS 2022-21 https://health.ec.europa.eu/system/files/2023-01/mdcg_2022-21_en.pdf

■Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/

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► 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

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#easymedicaldevice #medicaldevice #regulatorycompliance

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

Vigilance Reporting is a process that you should have but that you don’t want to us. In fact not having any vigilance reporting is a sign that you product is doing well. But having one means that maybe you need to improve your device.  
So on this episode we will explain to you what is Vigilance Reporting and how you should build it. We will explain EU reporting, UK, but also other regions. We will also mention about IMDRF guidances that are important. 

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► Who is Adam Isaacs Rar? 

Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.

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► 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.

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Links: 

LinkedIn profile Adam Isaacs Rae:  https://www.linkedin.com/in/adam-isaacs-rae/

Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/

► Social Media to follow

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

■ Twitter: https://twitter.com/elazzouzim

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

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

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#medtech #medicaldevice #compliance

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

Here is your Regulatory Update for the month of March 2023. Check all the links below

- EU MDR 2017/745 extension has been voted: https://www.raps.org/news-and-articles/news-articles/2023/2/europeanparliament-votes-to-extend-mdr-transition

-UK Impact of extension of Medical Device Regulations transitional period and the validity of Certificated in the EU: https://www.gov.uk/government/news/impact-of-extension-of-medical-device-regulations-transitional-period-and-thevalidity-of-certificates-in-the-eu

-Ireland - Article 97 request form : https://www.hpra.ie/homepage/about-us/publications-forms/forms-applications/item id=e4cb1326-9782-6eee-9b55-ff00008c97d0

-EU Team-NB. Best practice Guidance for the submission of Technical Documentation for IVDR: https://www.teamnb.org/team-nb-pp-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii-and-iii-of-in-vitrodiagnostic-medical-devices-regulation/

-EU Team-NB . IVDR technical Documentation training for manufacturers: Wednesday June 14th, 2023 https://www.teamnb.org/wp-content/uploads/members/M2023/Leaflet-IVD-TC-Manufacturers-Training-

-EMA pilots scientific advice for certain High-Risk Medical Devices:  https://www.ema.europa.eu/en/news/ema-pilotsscientific-advice-certain-high-risk-medical-devices

- New Notified Bodies ○ NSAI for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321463&version_no=10

○ MDC for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321397&version_no=8

-Spain AEMPS: Notice addressed to Notified Bodies and Manufacturers of Nasal Sprays with Virucidal or Microbicidal action: https://www.aemps.gob.es/informa/la-aemps-publica-una-nota-de-aviso-dirigida-a-organismos-notificados-y-a-fabricantesde-esprais-nasales-con-accion-viricida-o-microbicida/

-Swiss - Q&A for IVD notification: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_010d_mb_faq_invitro_diagnostika_meldungen.pdf.download.pdf/BW630_30_010e_MB_FAQ_Notifikationen_IVD.pdf

/search-fdaguidance-documents/guidance-industry-and-food-and-drug-administration-staff-assemblers-guide-diagnostic-xray-equipment

-Performance standard for Diagnostic X-Ray systems. https://www.fda.gov/regulatory-information/search-fdaguidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-majorcomponents-21cfr-102030-102031-102032

-Medical X-ray imaging devices coformance with IEC Standards: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-x-ray-imaging-devices-conformance-iec-standards

-List of cleared Companion Diagnostic: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-orapproved-companion-diagnostic-devices-in-vitro-and-imaging-tools

-US Medsun February 2023: https://www.fda.gov/media/165125/download

-SAUDI-DI Webinar March 20th 2023 https://www.sfda.gov.sa/en/workshop/87814

-Link to Webex: https://zoom.us/j/95729656046?pwd=NmNOLzZYT0hmK3JqVXhPQ25LQmQ5Zz09 -Link to Webex: https://zoom.us/j/93572022832?pwd=K1ZVL2xTNXFHV3NEdXVGbk4yN0Z3Zz09

-South Africa. SAPHRA Q&A on Licensing of Medical Device establishment: https://www.sahpra.org.za/wpcontent/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device- Establishments.pdf

○ Episode 219 - Biological Evaluation: Top Big Mistakes (Paul Fernandes and Laura Fouzari) https://podcast.easymedicaldevice.com/219-2/

○ Episode 220 - SaMD International Reach (Stephane Berger) https://podcast.easymedicaldevice.com/220-2/

○ Episode 221 - Prepare your transition from Class I to Class Ir https://podcast.easymedicaldevice.com/221-2/

○ LinkedIn Live - Samd Class I - To be published this week

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► 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

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#easymedicaldevice #medicaldevice #regulatorycompliance

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

The EU MDR is planning to be really challenging for Class I reusable Surgical Instruments as they will need to move to Class Ir. In this Episode Tautvydas from Test Labs will explain to us what is expected from the Medical Device Manufacturers. What they should prepare for being compliant to the new regulation.

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► Who is Tautvydas Karitonas?

Tautvydas is focused on accelerating access to market for medical devices. He has almost a decade of experience developing state of the art products for healthcare, which are now used in hospitals worldwide. Tautvydas provides expertise in product development, validation and problem solving.

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► 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.

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► Links from the Video

■ LinkedIn profile Tautvydas: https://www.linkedin.com/in/tautvydaskaritonas/

■ Test Labs webpage: www.testlabsuk.com

■ MDCG 2020-2 – Class I transition: https://health.ec.europa.eu/document/download/e87d08dc-87ab-49d9-8ffa-5552fa978d14_en

■ Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/

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► 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

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

We are in a global world, so normally what is good for the EU can be also good for other countries. But here the only barrier is local law. This is mainly what we will discuss on this Podcast. We will use the example of SaMD or Software as a Medical device for it and share with you the experience that we have but this is applicable to nearly all medical devices. Check the podcast page at: https://podcast.easymedicaldevice.com/220-2/

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► Who is Stéphane Berger?

Holder of a diploma in Electronics, with an experience of 25 years in the industry, after 10 years in the semiconductor field service business, he entered the medical device world in an ultrasound imaging company and started to implement ISO13485 requirements as customer service director and operation director. He began his career in quality and regulatory affairs in a recognized Notified Body with a position of auditor specialized in medical devices and software. He is currently holding the position of Regulatory and Quality Affairs Manager at Avicenna.AI, a French start-up that provides artificial intelligence solutions for radiology. Their products are registered in more than 40 countries worldwide and follow the evolving world of regulation around the Artificial Intelligence and Medical Device markets.

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► 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.

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► Links from the Video

■ LinkedIn Profile of Stéphane Berger: https://www.linkedin.com/in/bergerstephane ■ Avicenna Website: https://avicenna.ai/

■ WHO listing of Worldwide requirements: https://apps.who.int/iris/rest/bitstreams/1480622/retrieve

■ Authorized Representative Service: https://easymedicaldevice.com/authorised-representative-and-importer/

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► 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

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#easymedicaldevice #medicaldevice #regulatorycompliance

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

In this podcast episode, Laura and Paul will share with us the big mistakes done by some Medical Device manufacturers when they are considering Biological Evaluation for their products. 

You may need to take some notes as Laura and Paul are really knowledgeable on this process as they are onboarding some of their customers at ICARE Group and they will share with us the good, Bad and ugly. 

Don’t forget also to check their webpage to see what Icare can provide to you as a service. 

Who is Paul Fernandez? 

Holder of a Master’s degree in Toxicology and after a brief training in nutrition research, he began his career in regulatory affairs specialized in medical devices at ICARE when the MDR came into force. Curious by nature, and specialized in biocompatibility testing and in biological/toxicological risk analysis, he accompanies and guides many MD manufacturers in their biological evaluation strategy and after audit with authorities. He is currently Referent for the biological and toxicological safety of MD within Groupe ICARE. 

Who is Laura Fouzari? 

Following a master degree in toxicokinetics and toxicology, LF has specialized in the medical device sector and has started working on these themes  for 4 years. Nowadays, she is working as a safety and toxicological safety assessor in the Regulatory Affairs Unit within the Biotox Unit of Groupe Icare.

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. 

Links: 

• Icare Group: https://www.groupeicare.com/ 
• LinkedIn Paul Fernandez: https://www.linkedin.com/in/fernandesp 
• LinkedIn Laura Fouzari: https://www.linkedin.com/in/laura-f-712865150/ 
• FDA document: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and
• Webicare subscription: https://www.groupeicare.com/events/webicare-etude-alternative-focus-chimie/ 

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

Here is your Regulatory Update for the month of February 2023. Check all the links below

– EU amendment of the EU MDR and IVDR: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
– Proposal for extension consultation: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13684-Medical-devices-transition-period-extension_en
– Q&A: https://ec.europa.eu/commission/presscorner/detail/en/QANDA_23_24
– General Secretariat: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_5585_2023_INIT
– Vote: https://eur-lex.europa.eu/procedure/EN/2023_5?qid=1675093438485&rid=1

– EU Coverage of MDR code: https://health.ec.europa.eu/latest-updates/update-coverage-designation-codes-mdrivdr-notified-bodies-january-2023-2023-01-13_en

– EU list of Standard Fees for Notified Bodies: https://health.ec.europa.eu/latest-updates/mdcg-2023-2-list-standard-fees-january-2023-2023-01-12_en  

– EU Delegated directive for exemption for lead as a thermal stabilizer in Polyvinyl Chloride used as base material in sensors used in in-vitro diagnostic medical devices: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13594-Electrical-equipment-lead-in-polyvinyl-chloride-for-sensors-used-in-diagnostic-medical-devices-RoHS-exemption-_en

– MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of EU MDR and IVDR: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf  

– Annual overview of devices subject to the clinical Evaluation Consultation Procedure (CECP): https://health.ec.europa.eu/latest-updates/annual-overview-devices-subject-clinical-evaluation-consultation-procedure-cecp-april-2021-june-2022-2023-01-23_en  

– Training EU MDR 2017/745: https://school.easymedicaldevice.com/course/gb24

– UK government response to the consultation on Medical Device Regulation: https://www.gov.uk/government/publications/government-response-to-the-rhc-report-on-medical-devices  

– UK MHRA increases UK assessment capacity for In-Vitro diagnostic devices: https://www.gov.uk/government/news/mhra-increases-uk-assessment-capacity-for-in-vitro-diagnostic-devices  

– Swiss – FAQ on Medical Devices: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009e_MB_FAQ_Notifications.pdf

– Notified Bodies SLG Prüf und Zertifisierungs – 37 – EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=321000&version_no=11 https://www.slg.de.com/home.html

- EU MDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

- EU IVDR : https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 

– Saudi Arabia: Guidance AI/ML Software based: https://www.sfda.gov.sa/sites/default/files/2023-01/MDS-G010ML.pdf  

– Leading Voices in Medtech: https://lnkd.in/eUJcAQxE https://www.linkedin.com/posts/melazzouzi_medtech-easymedicaldevice-medicaldevices-activity-7025727213714997248-plJX?utm_source=share&utm_medium=member_desktop  

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

We talk a lot about Post Marketing Surveillance in Europe with EU MDR, MDCG, and all the rules to follow. But when you hear about how this is done in the US you will see that this is really completely different.

For that, I have invited Robert Packard to help us understand the rules behind it and also talk about an IT application that can help you to gather data for your PMS. Let's review that together.

Who is Robert Packard?

I have 20 years of experience in the medical device industry and another 10 years of experience in biotech manufacturing validation and scale-up. I am a UConn graduate in Chemical Engineering. I was Director of Quality and Regulatory Affairs at four different medical device start-ups, and I was President/CEO of a laparoscopic imaging company I co-founded in 2004. My quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009-2012, I was a lead auditor and instructor for BSI - one of the largest Notified Bodies for CE Marking and MDSAP Certification.

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.

Links 

• 522 Post-Market Surveillance Studies Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm
• Post-Approval Studies (PAS) Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm
• Post Market Management of Cybersecurity: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices
• MAUDE Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
• Basil Systems PMS Database Tool: https://basilsystems.com/easy-medical-device/
• Webinar on PMS EU and US: https://medicaldeviceacademy.com/post-market-surveillance-webinar/

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