Easy Medical Device Podcast

EU

Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF

Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf

Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_24_347/QANDA_24_347_EN.pdf

Factsheet: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-factsheet_1.pdf

MDCG 2024-1 Vigilance System for CE - Guidance and Template: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf

MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf

MDCG 2024-1-2 Coronary Stents and associated delivery systems: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf

MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf

MDCG 2024-1-4 Breast Implants: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf

Language requirements for Manufacturers (MDR & IVDR) - Check where English is not applicable:

MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf

IVDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf

eQMS

your eQMS SmartEye - The best eQMS ever:  https://eqms-smarteye.com

UK

Future Regulation roadmap - We still have to wait: https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf

Course

Training EU MDR Green Belt - February and March 2024 : https://school.easymedicaldevice.com/gb/

Notified Bodies and Approved Bodies

UK Approved bodies - They are 9 now: https://www.gov.uk/government/news/mhra-announces-two-new-uk-approved-bodies-to-certify-medical-devices
LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf

Scarlet NB UK: https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf

GDP video

Good Documentation Practices - Check how to be sure to have good documents: https://www.youtube.com/watch?v=nkBpef5AstI

ROW

USA

US FDA Quality Management System Regulation - Alignment to ISO 13485: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked

US FDA IVD Reclassification - Move from Class III to Class II: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds

FDA Remote Regulatory Assessment (RRA) - Question and Answers: https://www.fda.gov/media/160173/download

Estar 5.1 version -: IVD and non-IVD: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program

Non-IVD: https://www.fda.gov/media/174458/download?attachment

IVD: https://www.fda.gov/media/174459/download?attachment

eStar 5.0 video with Rob Packard: https://www.youtube.com/watch?v=KDkKnRnBfgc

Saudi Arabia

Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262

Manufacturing Devices at Point of Care (PoC) - uidance on how to manufacture them: https://www.sfda.gov.sa/sites/default/files/2024-01/MDS%20–%20G009E.pdf

Events

Medtech Conf - RAPS Workshop - Feb 27th until March 1st: https://medtechconf.com/event/raps-events/

Podcast Nostalgia - Relisten again and again

Episode 267 - Warning! Apply to your Notified Body Now! with Pritam Mekala: https://podcast.easymedicaldevice.com/267-2/

Episode 268 - You are not the Physical Manufacturer, can you be MDR certified: https://podcast.easymedicaldevice.com/268-2/

Episode 269 - Why you should use Pre-Submission or Q-Sub with FDA: https://podcast.easymedicaldevice.com/269-2/

Whatsapp Community:

Whatsapp community - Register even if it says no: https://chat.whatsapp.com/DvpnuGLihD98zGXsiYicQq

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

We always have a problem to contact regulators to ask them if our strategy is correct. In Europe, you cannot do that with a Notified Body unless you apply with one first and they cannot provide you with advice but just agree or disagree on your plan. Is it the same with the FDA. They have a specific pathway called Q-sub or Pre-Submission and you’ll see that this may be your Superpower to accelerate your success with your FDA application. Let’s listen to Saad Attiyah who will explain what is Q-SUB. 

Who is Saad Attiyah? 

Experienced Regulatory Affairs and Quality Assurance professional with 20+ years of experience in medical devices, in-vitro diagnostics, human/cell tissue products, and combination device/drug products. Proven experience with U.S., Canadian, and E.U. Regulators, submissions, and Global Strategy Development. Extensive experience authoring U.S. 510(k)’s, E.U. MDR Technical Documentation, HDE Supplement, HDE/PMA Change Assessments for Supplements, Letters to File, Q-Submission, and Canadian New Submission/Amendments. Certified Lead Auditor, QMS Expert, and Warning Letter Remediation.   

Areas of specialty: New Product Development Strategy for Global Markets, Maintenance and remediation of existing devices, clinical evaluation reports/trials, and compliance activities, QA/QC, SOP development.  

Device Types: Capital equipment and consumables such as blood analyzers and reagents, sterilizers and sterilant, ventilators, aspirators, centrifuges, implantable devices, single use medical devices, reusable instruments, and thermometry devices.

Device Classifications: US I through III, Canada Class II through IV, E.U. Class I through Class III, Compassionate Use  

510(k): K072866-Spinal Fixation System, K080281- Interbody Fusion Device, K090566- Novel Interbody Fusion Device, K091134- Anterior Cervical Plating, K092904 -Vertebral Body Replacement Device, K111009- Spinal Fixation System, K111774- Interbody Fusion Device, K153379- Orthopedic Plating, K161863- Shoulder Arthroplasty Devices w/expanded indications, K181091- Orthopedic Plating w/ Pediatric Indications. 

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: 

Saad Attiyah  LinkedIn:  https://www.linkedin.com/in/saadattiyah 

US FDA QSUB guidance :  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program 

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.

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.

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 from the Video:

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

 Useful Documents: https://www.gov.uk/government/publications/medical-devices-virtual-manufacturing-replaces-own-brand-labelling/virtual-manufacturing-of-medical-devices

 Virtual Manufacturer : Commission Recommendation 2013/473/EC. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2013:253:0027:0035:EN: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

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

Medica 2023 was really a great event and I am please to provide you here with a summary and interviews with multiple actors. You'll see that this is so diverse. We met with Startups, Service Providers, Notified Bodies and asked them the questions you would like to ask. So don't miss this opportunity first to understand what is MEDICA and second to hear what Notified Bodies are saying for example.

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 from the Video

linkedin Abhinav Jain: https://www.linkedin.com/in/4abhinavjain/ linkedin Diego

linkedin Stevanella:https://www.linkedin.com/in/diego-stevanella-25605310b

linkedin Anindya Mookerjea: https://www.linkedin.com/in/anindyamookerjea

linkedin Alessia Frabetti : https://www.linkedin.com/in/alessia-frabetti-6746465b/

linkedin ADNAN ASHFAQ :https://www.linkedin.com/in/adnan-ashfaq-44478121/

linkedin Stuart Angell: https://www.linkedin.com/in/stuartangellivd/

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.

The EU MDR 2017/745 was extended but does this change something for you? Do you need to apply to your notified body later? What can be the promise made by your Notified Body? Can they advice you? Pritam from TÜV SÜD will be answering my question without any taboo. So don't hesitate also to go to the show notes and see his details as at the end of the video he will be making you a promise. So don't miss this opportunity.

And if you need some support for your Notified Body application contact us at Easy Medical Device.

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.

Who is Pritam Mekala? 

Pritam Mekala is an enthusiastic, ambitious, and motivated medical device expert. Born in India, grew up in America, studied in the US, and currently living and working in Toronto, Canada, Pritam is an ensemble of multi-national, multi-cultural and multi-linguistic personality. He currently works at TÜV SÜD, as a Product Expert & Auditor in their Medical Health Sciences (MHS) Product Assessment Team (PAT). 

Before joining the Notified Body team, Pritam worked as a was project engineer at Abbott on their infamous BinaxNOW - COVID Test Kit project. He also worked at other notable medical device manufacturers such as Medtronic, Covidien, Zimmer Biomet etc.  

On the education front, Pritam graduated from the Oklahoma State University with a master’s in mechanical and aerospace engineering with research & specialization in Biomedical Engineering. 

As a representative of Notified Body, TÜV SÜD, Pritam can help you facilitate: 

Free 30minute Call (at no additional cost) *NOT CONSULTATION* 

Free Budgetary quote (for review & comparison) 

Free Technical Documentation Guidance (at no additional cost) 

Links from the Video

Profile LinkedIn:  https://www.linkedin.com/in/pritam-mekala/

Email: [email protected] 

Company website: https://www.tuvsud.com/en-us 

Relevant MDCG Announcements: 

https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf 

https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf 

https://health.ec.europa.eu/latest-updates/mdcg-2022-14-transition-mdr-and-ivdr-notified-body-capacity-and-availability-medical-devices-and-2022-08-26_en 

TÜV SÜD Structure Dialogue:  

https://ts.tuvsud.com/rs/819-PVY-502/images/T%C3%9CV%20S%C3%9CD%20Structured%20Dialogue%20-%20customer%20presentation.pdf?version=0&mkt_tok=ODE5LVBWWS01MDIAAAGO-2Fg5uIG2idWOUuPQkEspBBKLOHU1vf9rLoMqzR2t_pnXJguMMpidTQA5rQbAJ-uIcPpYp3S4QS8SV6R1wE2GeN8IJNMyV2HJf24YyQdGxo

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.

Medboard

Who is Medboard

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

EU

 EU Reference laboratories EURL

EU Reference laboratories for IVD products: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302713

Article : https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-12-06_en

Letter to EU Parliament

 Letter sent to the European Parliament - Cybersecurity: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_17000_2023_INITMDCG 2023-7 on Clinical Investigation

MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR: https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf

MDCG 2019-07 rev 1 on PRRC

MDCG 2019-07 Rev 1: Guidance on Article 15 of MDR and IVDR on PRRC: https://health.ec.europa.eu/system/files/2023-12/md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf

MDCG 2021-27 on Importer and Distributor

MDCG 2021-27 Rev 1 Q&A Article 13 & 14 MDR and IVDR: https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf

MDCG 2023-5 on Annex XVI class

MDCG 2023-5 Guidance on qualification and classification of Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-5_en.pdf

MDCG 2023-6 on Annex XVI Equivalency

MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products: https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-6_en.pdf

Companion Diagnostics CDx

EMA Q&A on Companion Diagnostics CDx: https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-medicinal-products-development-and-assessment-involving-companion-diagnostic-cdx_en.pdf

Switzerland

Guidance on Devices with no medical purpose

Medical Device without Medical Intended Purpose: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf

Emergency use of non-conform device

Exemption to Medical Device non-conforming: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw617_00_003d_mb-ausnahmebewilligung-mep.pdf.download.pdf/BW617_00_003e_MB%20Derogation%20MEP.pdf

Notified Bodies:

New Notified Body under EU MDR

43rd NB MDR - CESKY METROLOGICKY INSTITUT - Czech Republic: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=17f0c069619116060627ac0f430dff1c8cbc295c&group=NOTIFICATION&download=true

Notified Body Situation

Notified Body Situation; https://health.ec.europa.eu/system/files/2023-12/notifiedbodies_overview_en.pdf

Training:

EU MDR training

Green Belt training

28th edition January 22nd until 28th https://school.easymedicaldevice.com/course/gb28/

29th edition February 19th until 23rd https://school.easymedicaldevice.com/course/gb29/

30th edition March 25th until 29th https://school.easymedicaldevice.com/course/gb30/

Medical Device e-Training

eTraining

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

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

ROW

Mexico:

Mexico registration rules

Guide for obtaining the Health Registry of Medical Devices - https://app.medboard.com/your-medboard/systematic-reviews/authorities-news/2243/

Brazil:

Brazil is calling Innovative Medical Devices

Innovative Medical Devices: Anvisa extends deadline for participation in pilot project: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/dispositivos-medicos-inovadores-anvisa-prorroga-prazo-de-participacao-em-projeto-piloto

Hong-Kong:

Hong-Kong Guidances

Artificial Intelligence Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR008.pdf

Software Medical Devices and Cybersecurity: https://www.mdd.gov.hk/filemanager/common/mdacs/TR007.pdf

Guidance note for Listing Class II/III/IV General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf

Guidance note for Listing Class B, C, D In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf

Classification of In-Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf

USA:

USA Export documents transition to digital

Transition to Electronic Export Documents - Letter to Industry: https://www.fda.gov/medical-devices/industry-medical-devices/transition-electronic-export-documents-letter-industry

India:

India New platform to register

National Single Window System (NSWS) Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTA=

Australia:

Australia Boundary and Combination products

guide on boundary and combination products https://www.tga.gov.au/sites/default/files/2023-12/guidance-boundary-combination-products.pdf

Australia on Custom-Made and Patient Match

How to submit a custom-made medical device / patient-matched medical device notification: https://www.tga.gov.au/sites/default/files/2023-12/How-submit-custom-made-medical-device-patient-matched-medical-device-notification-guide.pdf

Malaysia

Malaysia is telling rules on Borderline products

Harmonised borderline products in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-borderline-products-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWJvcmRlcmxpbmUtcHJvZHVjdHMtaW4tYXNlYW4tc2Vjb25kLWVkaXRpb24tMi1wZGYiLCJpYXQiOjE3MDIzNDcxOTksImV4cCI6MTcwMjQzMzU5OX0.4cNrbv3GpbG2KjL6uQxcxm3KeBGLsxZy77JqQKiIXUc

Malaysia is telling rules for classification of products

List of harmonized classification of Medical Devices in ASEAN: https://www.mda.gov.my/index.php/doclink/guidance-document-harmonised-classification-of-medical-device-in-asean-second-edition-2-pdf/eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJzdWIiOiJndWlkYW5jZS1kb2N1bWVudC1oYXJtb25pc2VkLWNsYXNzaWZpY2F0aW9uLW9mLW1lZGljYWwtZGV2aWNlLWluLWFzZWFuLXNlY29uZC1lZGl0aW9uLTItcGRmIiwiaWF0IjoxNzAyMzQ3MTk5LCJleHAiOjE3MDI0MzM1OTl9.WbMya1V8vykQ88aQyqpraMR4G7rZ_QA36hN_DOEeqso

Podcast Nostalgia

Podcast Nostalgia

Episode 262 - What is usability: https://podcast.easymedicaldevice.com/262-2/

Episode 263 - Why you should invest in your Regulatory Team: https://podcast.easymedicaldevice.com/263-2/

Episode 264 - Life of a QA RA Podcaster https://podcast.easymedicaldevice.com/264-2/

Episode 265 - Heatmap: https://podcast.easymedicaldevice.com/265-2/

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

This presentation was recorded during MEDICA COMPAMED 2023. Stefan Bolleininger from Be on Quality did share with us the information about HEATMAP for Regulatory Affairs. The idea is mainly to be able to improve the visualisation of a certain state of your department or project. There will be the collection of data, the scoring, then the creation of the heatmap, the colour coding, the visualization, and analysis/actions. 

So, if you want to find a refreshing way to present the situation of your projects, don’t hesitate to learn this with this presentation. And download the presentation within the link below. 

Who is Stefan Bolleininger? 

Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in 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: 

Stefan Bolleininger LinkedIn Page:  https://www.linkedin.com/in/stefan-bolleininger-3a717028/ 

Be on quality  website: http://www.be-on-quality.com/en/home-en/ 

Download presentation: https://mailchi.mp/easymedicaldevice/265-heatmap 

Medica Website: https://www.medica-tradefair.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.

Easy Medical Device has its podcast and many other Quality and Regulatory Affairs people are also doing podcasting. I have met with Claudia and Jorg who are also having a podcast and we reviewed our experience and encouraged people to also start their podcast. Check our experience and learn from it. 

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: 

Claudia Dannehl Linkedin Profile: https://www.linkedin.com/in/claudia-dannehl/ 

Jorg Brokmann Linkedin Profile: https://www.linkedin.com/in/j%C3%B6rg-brokmann-051438249/ 

Podcast Spotify: https://open.spotify.com/show/1H9MS4y7RmDQsDxM4DfDow?si=3e6b684150c049d1 

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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Regulatory affairs teams have an outsized impact on business revenue, bringing new products to market quickly, managing registrations and licenses to keep products on the market, and staying updated on changing standards and regulations that might impact market clearance. Yet most regulatory affairs teams are treated primarily as operational cost-centers, resulting in poor productivity measurement, unclear objectives, and limited investments in people and technology.   
  
During this podcast episode, we’ll discuss why medtech companies should invest in their regulatory teams 

Who is James Gianoutsos? 

James Gianoutsos is the Founder & CEO of Rimsys Regulatory Management Software, a cloud-based solution to digitize, automate, and create regulatory order for MedTech companies. James is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. His professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. James also has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, MDR, MDSAP, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business. 

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

James Gianoutsos LinkedIn:  https://www.linkedin.com/in/jwgianoutsos/ 

Rimsys website: https://www.rimsys.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.

The Medical Device field is so big that we have a specialist for each type of area. This is like a Surgeon that is specialist of the heart, the orthopaedic… Here we have with us a specialist for Usability, and this is really a big filed that you need to understand. IEC 62366 is a standard that is important to know as all devices that have a user interface should show they can be safe, and that user understands it. So, don’t miss this episode. 

Who is Michael Engler? 

Senior Consultant, Managing Partner at Benkana Interfaces GmbH & Co. K

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 Engler LinkedIn Page:  https://www.linkedin.com/in/michael-engler-benkana/

Benkana Interface website: https://www.benkana-interfaces.com/

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