Easy Medical Device Podcast

Medboard

Medboard platform  Sponsor of the podcast https://www.medboard.com/

EU

EPSCO Meeting November 30th. 2023  -  MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf

Survey on Medical Devices -   Study supporting the monitoring of the availability of Medical Devices on the EU Market.

Information: https://ec.europa.eu/eusurvey/runner/MFandAR

Questionary: https://ec.europa.eu/eusurvey/files/6a4fd4cd-dfce-4fe1-bcaf-9f44eb00e471/650fed06-30d2-40b1-9ff0-e96c79b4eb96

Falsification of Medical Devices - Survey result: https://act.edqm.eu/s/XcPw5MDtYe49gmj/download/CMED-Survey-Report-Final%20%281%29.pdf

MDCG 2022-11 Rev 1 Position Paper - Call to NB to streamline the certification process https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf

EU IVDR Technical Documentation training - TEAM-NB Survey result

Training IVDR technical documentation February 1st, 2024: https://www.team-nb.org/wp-content/uploads/2023/11/Leaflet-IVD-TD-Manufacturers-Training-20240201.pdf

Result on Survey of MDR training: https://www.team-nb.org/mdr-technical-documentation-training-for-manufacturers/

DEHP Substance forbidden in Medical Devices - Extension to July 1st, 2030 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482Notified Bodies Situation - 2 new comers:

UDEM Turkey 41st NB under MDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7Scarlett NB B.VC. 42nd NB under MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=2feeb6d10d338167081ad0cf7af6683fe760cded&group=NOTIFICATION&download=true

Switzerland

Vigilance Reporting submission information  - Update your QMS procedures: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/uebersicht-medizinprodukte/archiv/hinweis-einreichung-vigilance-meldungen-mep.html

Training EU MDR

Training EU MDR 2017/745 - December 11th - Green Belt Certification Program for EU MDR : https://school.easymedicaldevice.com/course/gb27

Medtech Conf

Your Medtech Conferences -  Register all your Events, Training, Conferences: https://medtechconf.com/

USA

FDA withdrawal - not anymore member of the GHWP: https://www.fda.gov/media/174142/download

Discontinuation in the USA - Notifying FDA of a permanent discontinuation: https://www.fda.gov/media/155245/download

Webinar on Companion Diagnostics - Oncology Drug Products used with IVD tests: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program-12122023Canada

Medical Device Establishment Licenses annual review - You should receive your Christmas Package: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2024.html

Saudi Arabia

Webinar: Clinical Trials of Medical Device Requirements - Click on the link in December 12th, 2023: https://www.sfda.gov.sa/en/workshop/93098South Africa

Guideline on Q&A for Licensing of Medical Device Establishment - Learn how to start this activity: https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf

Brazil

Argentina & Brazil signed a Mutual Recognition Agreement - For certificates for Medical Devices: https://www.argentina.gob.ar/noticias/anmat-y-anvisa-firmaron-el-primer-acuerdo-de-reconocimiento-mutuo-en-certificados-para

SmartEye

eQMS for Medical Device companies - Get your Demo now: https://smart-eye.io

Podcast Nostalgia

How to CE certify a calculator, risk score software as Medical Device? Cesare Magri: https://podcast.easymedicaldevice.com/258-2/

How to find a predicate Device for your 510k submission? Beat Keller: https://podcast.easymedicaldevice.com/259-2/

What is the situation regarding Digitalization in the Medtech industry? MedXD https://podcast.easymedicaldevice.com/260-2/

Easy Medical Device support - [email protected]

Social Media to follow

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

Twitter: https://twitter.com/elazzouzim

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

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

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

Don’t miss this panel discussion that happened during the MEDXD in Berlin (26 and 27 September). Medical Device companies are moving to digitalize their processes and MDKU association did create the MEDXD conference where the discussions from multiple companies helped to understand the status.

Monir El Azzouzi moderated this panel and asked questions following the presentation that were provided.

This panel discussion was composed of

Karim Djamshidi

Vice President Global Patient Health & regulatory Compliance, Karl Storz

https://www.linkedin.com/in/karim-djamshidi/

Denise Wocko

Head of Global Client Portfolio Management, RQM+

https://www.linkedin.com/in/denisewocko/

Sarah Haake-Schäfer

Head of Quality Management, Regulatory & Clinical Affairs, Carl Zeiss Vision
https://www.linkedin.com/in/sarah-h-981a94226/

Markus Pöttker

PMS Lead – Safety & Surveillance, Smith + Nephew,
https://www.linkedin.com/in/markuspoettker/

Sarah Panten

Managing Partner / Strategic Business & Product Development, avasis

https://www.linkedin.com/in/sarahpanten/

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:

MEDXD link: https://medtechx.digital/

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 choice of a Predicate Device is important and challenging at the same time. Your predicate device is already on the US market, so all you must do is select it and confirm that your device is the same as the predicate and Bingo, you can register your product in the US. But this is not as simple as that. Beat Keller from imt in Switzerland will share with us his experience working on US submissions and provide some hints on what you should or should not do. 

Who is Beat Keller? 

Beat is the Head of Regulatory Affairs and Quality Management at IMT, a Swiss Consultancy and Engineering Service provider for medical device manufacturers. He has worked for more than 10 years in the medical device industry first as a software engineer, then as a project leader before he took over the Regulatory and Quality department of IMT. 

Beat is also active in different standards working group as Co-Convenor of the “conformity assessment” working group of the Swiss standards association and member of different working groups on Swiss, European and International level for medical device 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: 

Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/

imt website: https://www.imt.ch/ 

US FDA predicate device guidance: https://www.fda.gov/media/171838/download 

MDCG Guidance on Equivalent Devices: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.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.

We have a lot of sort of Software as Medical Devices. Today I wanted to ask to Cesare Magri some questions about APIs. First what they are, and can they be a Medical Device. He will also give us some advice on what to do if your API is really a medical device. So stay tuned.

Who is Cesare Magri?

Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diagnostic manufacturers by leveraging clinical and non-clinical data for certification and marketing purposes. He has contributed to more than 100 clinical and performance evaluation for devices of all risk classes.

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

■ Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri/

■ 4BetterDevices website: https://4betterdevices.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.

EU:

UDI for contact lenses  Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197

EUDAMED Roadmap It is a DRAFT: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf

MDCG 2023-4 guidance - Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf

Fees and charges payable to EMA: Expert Panel will cost you money : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_14057_2023_INIT

Notified Bodies : Finland and Turkey

Sertio Oy (Finland) IVDR: https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1001622Notice Belgelendirme (1st Turkish Notified Body) MDR: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=82870fd17389fc19149f103e8121acdc82fea1af&group=NOTIFICATION

Team-NB call for action to Manufacturers to apply: https://www.team-nb.org/wp-content/uploads/2023/10/Team-NB-PressRelease-Capacity-NotifiedBodies-during-transition-IVDR-MDR-October2023.pdf

Training for you

Increase your knowledge in QA RA :

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

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

Green Belt training: December 11th until December 15th: https://school.easymedicaldevice.com/course/gb27

Spain:

Implementation of the HTA : EU Health Technology Assessment Regulations: https://www.aemps.gob.es/la-aemps/de-la-teoria-a-la-practica-implementacion-del-reglamento-de-evaluacion-de-tecnologias-sanitarias-de-la-ue/

Regulation 2021/2282 on health technology assessment: https://health.ec.europa.eu/publications/regulation-eu-20212282-health-technology-assessment_en

Switzerland:

Products without an intended medical purpose : Same as EU MDR: 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
Obligation Economic Operators -: Update due to extension  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_016d_mb_pflichten_wirtschaftsakteure_ch.pdf.download.pdf/MU600_00_016e_MB_Obligations_Economic_Operators_CH.pdf

General procedure for foreign governmental inspections - Inform Swissmedic before governments audit a manufacturer  https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/i-308/i-308_aa_02-A01e_general_procedure_for_foreign_governmental_inspections_switzerland.pdf.download.pdf/I-308.AA.02-A01e_Merkblatt_General_procedure_foreign_govern_insp_CH_related_therapeutic_prod.pdf

MedTech Conf

Map of conferences available

Conferences Map: https://medtechconf.com/

Medica Dusseldorf November 13 -15 : https://medtechconf.com/event/medica-2023/

TEAM-PRRC Strasbourg November 16 - 17: https://medtechconf.com/event/team-prrc-annual-summit-2023/

Turkey:

Product not considered as a Medical Device - List of products available: https://titck.gov.tr/duyuru/tibbi-cihaz-yonetmelikleri-kapsaminda-degerlendirilmeyen-urunler-30102023120556

eQMS SmartEye:

SmartEye is your eQMS - Ask for your DEMO : https://smart-eye.io/

USA:

eStar is your new 510k : Since October 1st, 2023: https://www.fda.gov/media/152429/download

Australia:

Webinar on UDI for Australia - November 21st, 2023 11.30 AEDT: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-udi-webinar-19-australian-udi-project-update-and-discussing-considerations-and-real-world-benefits-adopting-udi-healthcare

Podcast Nostalgia : You remember

What are some pitfalls to avoid during Software Design? Weronika Michaluk: https://podcast.easymedicaldevice.com/253-2/

Affrisummit 2023 Part 1 Morad Ajan, Rana Chalhoub, Dr. Mona Al Moussali: https://podcast.easymedicaldevice.com/254-2/

Afrisummit 2023 Part 2 Nora El-Hariri and Mohamed Mahdy Ghonim: https://podcast.easymedicaldevice.com/255-2/

Validate your iPhone, Samsung Galaxy, Huawei for your Software Erik Vollebregt: https://podcast.easymedicaldevice.com/256-2/

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

This MDCG came like evidence but comments on it where more confusion. What exactly was the objective of the MDCG 2023-4. We will try to explain to you on this podcast with Erik Vollebregt from Axon Lawyers.

Who is Erik Vollebregt?

Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

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

■Erik Vollebregt LinkedIn:  https://www.linkedin.com/in/erikvollebregt/

■Axon Lawyers website:  https://www.axonlawyers.com/

■MDCG 2023-4: https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf 

■Blog post: medicaldevicelegal.com 

■Book: https://erikvollebregt.gumroad.com/ 

■Blue guide: https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en 

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 Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders. This is the part 2 where we will focus on the Egypt situation.  

Check Part 1 for the first interviews with (https://podcast.easymedicaldevice.com/254-2/): 

- Morad Ajan - Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) – Morocco 

- Rana Chalhoub - Regulatory Affairs Director at Mecomed.  

- Dr. Mona Al Moussali - Co-founder PRA Consultancy and organizer of the Afrisummit.  

In this part 2 we have: 

- Noha El-Hariri – Head Regulatory Affairs Medical Device  

- Mohamed Mahdy Ghonim – IVD Manufacturer in Egypt 

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 

■ Noha El-Hariri LinkedIn Page: https://www.linkedin.com/in/noha-el-hariri-a46a1285/ 

■ EDA Webpage: https://www.edaegypt.gov.eg/ 

■ Mohamed Mahdy Ghonim LinkedIn Page: https://www.linkedin.com/in/mohamed-ghonim-1444102b/ 

■ Mohamed Mahdy Ghonim Qualitech International: https://www.qt-int.nl/ 

■ Thequa medical: https://www.thequa-med.com/ 

■ Afrisummit: https://www.linkedin.com/company/pharmaregafrisummit/ 

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 Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders. 

First, I have the interview with Morad Ajan - Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) - Morocco. We reviewed the Quality and Regulatory situation of Morocco and learned a lot of good information about progress that the authorities are ongoing to be modernized. 

Second, we have the interview with Rana Chalhoub - Regulatory Affairs Director at Mecomed. We reviewed the situation in Middle East and Africa and why a summit like Afrisummit is important. 

Third, the interview with Dr. Mona Al Moussali - Co-founder PRA Consultancy and organizer of the Afrisummit. We reviewed how the summit went and what are some feedback out of 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 

Morad Ajan LinkedIn Page:  https://www.linkedin.com/in/ajanm/ 

DMP website: https://dmp.sante.gov.ma/ 

Rana Chalhoub LinkedIn Page: https://www.linkedin.com/in/rana-chalhoub-8a391214/ 

Mecomed website: https://www.mecomed.com/ 

Dr Mona Al Moussali LinkedIn Page: https://www.linkedin.com/in/mona-almoussli/ 

PRA Consultancy Website: https://pra-me.com/ 

Afrisummit: https://www.linkedin.com/company/pharmaregafrisummit/

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.

More and more companies are starting to develop Software as Medical Devices (SAMD) and in this podcast episode, I have invited Weronika Michaluk to talk to us about some pitfalls that you need to avoid. 

Weronika will talk about: 

- Risk Management 

- Usability 

- Documentation 

- Expertise 

- Interoperability and scalability 

- Cybersecurity. 

So don’t miss that and don’t hesitate to contact Easy Medical Device if you have some questions. 

Who is Weronika Michaluk? 

Weronika Michaluk is an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. She is a Biomedical Engineer by training, holds a Master's degree in International Business from the University of Miami, an MBA from the Warsaw School of Management, and a Doctorate in Public Health (DPH) with a specific focus on the business strategy of Agile Development of Software as a Medical Device (SaMD).  Weronika's career began as a Biomedical Engineer, where she contributed to the development of various biomedical devices, including a wireless ECG system, then she worked in South Korea in the Neuroscience Department and after that she focused on digital health solutions and consulting in the medical device space. 
 
Currently, Weronika serves as the Digital Health Principal and SaMD Lead at HTD. In this role, she leads the Software as a Medical Device department, utilizing her expertise in biomedical engineering and business acumen. Her primary objective is to ensure that all products are meticulously designed and developed, adhering to the highest quality standards. Weronika's dedication to customer satisfaction and patient safety is instrumental in driving the success of the organization and its customers.  

 
In her free time Weronika enjoys learning new languages (speaks 5 currently), travelling the world, playing sports, hiking ( she recently hiked Kilimanjaro, plans to hike to Mount Everest base camp next year) and discovering the unknown. 

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

Weronika Michaluk LinkedIn Page:  https://www.linkedin.com/in/weronika-michaluk-mba-43811698/ 

HTD Health website: https://htdhealth.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.