Easy Medical Device Podcast

This episode will alert you about the UKCA deadline for the UK market. So if you are selling products to the UK or if you plan to, you need to listen to what Adam Rae will tell you.

We will mention the rules for UKCA, the documentation needed for the Approved Body situation, and also the Northern Ireland Situation.

So no need to read all the regulations, we will summarize the situation here and you will need to act immediately after that.

Who is Adam Rae?

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 the Medical Device Regulations worldwide. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links

• LinkedIn: https://www.linkedin.com/in/adam-isaacs-rae/
• Website: theotherconsultants.com
• Substack newsletter: https://theotherconsultants.substack.com/
• Download cheat sheet: https://mailchi.mp/easymedicaldevice/podcast-episode-186-ukca

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

When we think of ISO 13485 certificate we mainly associate it with Medical Device manufacturers. But this can be also associated with other Medical Device Economic Operators.

In this episode, Cristina Miroescu (Compliance Director at Sofmedica) will explain to us why Sofmedica decided to be ISO 13485 certified. You'll hear about their journey with the Plus and Minus. We are sure this may help you understand the process of certification if you are an importer or distributor.

Who is Cristina Miroescu?

Cristina joined SofMedica in 2000 as the first regulatory person preparing files for medicinal product and medical devices registration. Later on, as Regulatory Manager her role was to integrate the legal provisions and regulations into the company’s business strategy.

She used to manage quality management systems, vigilance, pharmacovigilance, regulatory, compliance, and warehouse management. As a Group Compliance Director Cristina is responsible to ensure the compliance of the company’s activity with the applicable legislation and requirements with a focus on contributing to building a quality culture of integrity, transparency, and honesty.

An important part of Cristina’s activity was focused between 2010 – 2015 in the medical services field in another company of SofMedica group when she was managing the quality management system, permits obtaining and maintenance for 15 dialysis centers in Romania. Cristina holds a bachelor’s degree in Pharmacy.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses...

Links

• Cristina Miroescu Linkedin: https://www.linkedin.com/in/cristina-miroescu-4255a6164/
• Sofmedica website: https://sofmedica.com/
• Video Sofmedica:

  https://www.youtube-nocookie.com/embed/qqc1yAxMwdM?feature=oembed

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

In this episode, Karandeep Badwal will introduce you to the common mistakes that we can see within your company for Quality and Regulatory affairs.

• Software validation
• Supplier evaluation
• Clear procedures
• Internal audits
• CAPAs
• SaMD
• Vigilance reporting
• Standards
• Unannounced audits

Who is Karandeep Badwal?

Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses...

Links

• Karandeep Badwal LinkedIn: https://www.linkedin.com/in/karandeepbadwal/
• Youtube channel: https://www.youtube.com/c/QRAMedical
• Podcast:

  https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3?si=4224628dd6d840e8

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.

Here is your Medical Device Regulatory update. This will be focused on the IVDR 2017/746 that went live. So let's update you on some key changes. 

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses... 

Links

NEWS

- Swiss: MRA situation for IVDR; https://ec.europa.eu/health/document/download/8dd260fd-0b67-415b-bf1e-36bdf8681674_en?filename=md_eu-switzerland_mra_in-vitro-diagnostic.pdf

- Swiss: new IvDV (Ordinance on in-vitro diagnostics): https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html

○ Swiss Odiv: https://www.fedlex.admin.ch/eli/cc/2022/291/fr

- Swiss: Performance studies of IVD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/leistungsstudien.html

○https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf

- EU: Team NB Survey: https://www.team-nb.org/wp-content/uploads/2022/05/Survey-2021-20220516.pdf - EU: Harmonized standard for IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0729

- EU: Harmonized standard for MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0757

- Italy: Establishment of the National Surveillance Network: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5894

- Preparing for UKCA marking of Medical Device with Ronald Boumans: https://boumansconsulting.com/expert-center/tip-of-the-week/preparing-for-ukca-marking-of-medical-devices/

- Green Belt Certification June 2022: https://school.easymedicaldevice.com/course/gb19/

NOTIFIED BODY

- 3EC International - IVDR 2017/746 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3

- TÜV Nord - EU MDR 2017/745: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317538&version_no=8

- Berlin Cert - EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43955

- Overview NB each stage: https://ec.europa.eu/health/system/files/2022-05/notifiedbodies_overview_en.pdf

GUIDANCE

- MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR: https://ec.europa.eu/health/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf

- MDCG 2022-7 Q&A UDI System: https://ec.europa.eu/health/document/download/b5429d14-25a9-4cfc-b059-355388f03e05_en?filename=mdcg_2022-7_en.pdf

- MDCG 2022-8 IVD Legacy devices: https://ec.europa.eu/health/document/download/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf

- MDCG 2022-9 Summary of safety and performance template: https://ec.europa.eu/health/document/download/b7cf356f-733f-4dce-9800-0933ff73622a_en?filename=mdcg_2022-9_en.pdf

- MDCG 2022-10 Q&A interface 536/2014 on clinical trials for medicinal products for human use and IVDR: https://ec.europa.eu/health/document/download/59abcc81-fd32-4546-a340-24c8fad4e2ac_en?filename=mdcg_2022-10_en.pdf

PODCAST

- Episode 179 - How to certify your Software as a Medical Device? With Vivek Thakkar: https://podcast.easymedicaldevice.com/179/

- Episode 180 - What happens after the IVDR Date of Application with Colm O'Rourke: https://podcast.easymedicaldevice.com/180/

- Episode 181 - What to learn about the EU Medical Device Situation? https://podcast.easymedicaldevice.com/181/

-Episode 182- Let's introduce our eQMS Smarteye with Anindya Mookerjea: https://podcast.easymedicaldevice.com/182/

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Big news, with my partners we have developed an eQMS called SmartEye!!! and we wanted to share with you why an eQMS is needed. For that, I have invited Anindya Mookerjea the CEO of SCube Technologies. We will talk about eQMS solutions and how the idea of SmartEye came. I was part of the development of certain modules and this is really satisfying to see that auditors or customers like them. Don’t forget to ask for a demo.

Who is Anindya Mookerjea?

Anindya is the founder and CEO of S-Cube Technologies. He has over 20 years of experience in the medical device & Software industry. Experienced in taking medical device concepts through design & development, regulatory submission, and to market. Expert in the design, development, and implementation of FDA/ISO compliant quality management systems for Medical devices & Software medical devices. Industry expert in Agile methodology implementation for Software medical devices. Strong background in testing Software medical devices. The brainchild of SmartEye product.

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 the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links

• Anindya Mookerjea Linkedin Profile: https://www.linkedin.com/in/anindya-mookerjea-6b5367209/
• SCube Technologies website: https://scube-technologies.com/
• SCube Technologies Linkedin Page: https://www.linkedin.com/company/scube-technologies/
• Twitter account: https://twitter.com/scubetechno
• Facebook account: https://www.facebook.com/i.scubetechnologies
• Article Medical Device development: https://easymedicaldevice.com/medical-device-development/

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

The Medtech Forum occurred this year in Barcelona between May 3-5, 2022 During this conference, we recorded a podcast episode with Erik Vollebregt to summarize the discussions that happened. The topics that we will cover are:

• Health Technology Assessment (HTA)
• Digitalization for Medical Devices post-Covid
• EU Commission not providing all the answers
• Centralization for Medical Devices like FDA or EMA
• Extension of EU MDR
• Legacy devices versus New devices
• New technologies pathway
• EU Market versus US Market

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, and 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 in 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 and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses...

Links 

• Medtech Europe: https://www.medtecheurope.org/
• Erik Vollebregt profile: https://www.linkedin.com/in/erikvollebregt/
• Axon lawyers: https://www.axonlawyers.com/
• HTA EU Commission: https://ec.europa.eu/health/health-technology-assessment/overview_en
• Podcast episode 173 - EU MDR extension: https://podcast.easymedicaldevice.com/173/

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

The IVDR 2017/746 will become live on May 26th, 2022 and this will be the big day for a lot of IVD companies.

To talk about the situation under IVDR, I have invited Colm O’Rourke from Trinzo to help us. Colm is sharing with us the situation for manufacturers. Also about Notified Bodies.

Who is Colm O’Rourke?

Colm O’Rourke is a regulatory and quality consultant with 10 years’ experience working in the medical device industry, including notified body, diagnostics manufacturer, and clinical laboratory experience. Colm works with manufacturers to achieve compliance through strategic planning, supporting the development of compliant technical and quality documentation, and assisting with regulatory submissions. Colm also delivers training on a number of topics including EU MDR and IVDR. Colm is a graduate of UCC, Ireland with a BSc in Biomedical Science, and NUI Galway, Ireland with a Dip. in Medical Device Science

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links

• Colm O’Rourke LinkedIn Profile: https://www.linkedin.com/in/colm-o-rourke-37b53044/
• MedDev Solutions Website: https://www.meddevsolutions.co.uk/
• MDCG 2022-6 IVDR significant changes: https://ec.europa.eu/health/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf
• Meddev Solutions IVDR training: https://www.meddevsolutions.co.uk/euivdr
• EU IVDR Guidebook (10% off with the code: EASYMEDICALIVD): https://www.meddevsolutions.co.uk/ivdrguidebook

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.

Do you have a Software as a Medical Device or maybe you plan to have one? Then listen to this episode with Vivek Thakkar which will provide you some insight on what is SaMD and how to get Certified. If you need more details, please contact us so we can help you.

Who is Vivek Thakkar?

Regulatory affairs professional with a Master’s degree and 12 years of experience with Class II and Class III medical devices. Currently supporting regulatory activities for Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD). Proven success in building and executing global regulatory strategies for interventional cardiovascular products. Skilled at hiring, training, and inspiring regulatory experts for medical device submissions. Passion for simplifying

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links

• Vivek Thakkar Linkedin: https://www.linkedin.com/in/vivekbthakkar/
• Blog post SaMD: https://easymedicaldevice.com/SaMD
• Clinical Evaluation Software: https://www.youtube.com/watch?v=HIycmCuBsi0

Social Media to follow

• Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• Twitter: https://twitter.com/elazzouzim
• Pinterest: https://www.pinterest.com/easymedicaldevice
• Instagram: https://www.instagram.com/easymedicaldevice

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

In this episode, I will update you regarding all the changes in the Medical Device Quality and Regulatory Field. Below are all the topics we will discuss during this episode. Don’t miss the latest updates.

EU

• EUDAMED & Certificate: https://ec.europa.eu/health/medical-devices-eudamed/notified-bodies-and-certificates-module_en
• EUDAMED Notified Body User guide: https://ec.europa.eu/health/document/download/8b6132fd-75ed-4e8b-8be5-920725037221_en?filename=md_eudamed-nb-user-guide_en_0.pdf
• EUDAMED Economic Operator User Guide: https://webgate.ec.europa.eu/eudamed-static/documents/assets/guides/user_guide_eo_en.pdf
• Delegated acts: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2022:182:FIN
• TURKEY: Reminder custom agreement: https://ec.europa.eu/health/latest-updates/notice-stakeholders-eu-turkey-customs-union-agreement-field-medical-devices-2022-04-13_en
• Spain: CCPS registration of IVD until EUDAMED is fully available: https://www.aemps.gob.es/informa/notasinformativas/productossanitarios/2022-ps/informacion-sobre-la-comunicacion-de-productos-sanitarios-de-diagnostico-in-vitro-en-ccps/

USA

• MDSAP Audit Approach: https://www.fda.gov/media/157861/download
• FDA: Refuse to accept Policy for 510k: https://www.fda.gov/media/83888/download
• FDA Medsun Newsletter: https://www.fda.gov/media/157448/download

MEA

• Ethiopia: Labelling requirements: http://www.fmhaca.gov.et/wp-content/uploads/2022/04/Guidelines-for-Medical-device-Labeling.pdf

ASIA

• Malaysia: Labelling requirements: https://www.mda.gov.my/documents/draft-guidance-documents/1969-attachment-1-public-comment-mda-gd0026-requirement-on-labelling-of-md/file.html

EVENT

• Medtech Forum: https://www.themedtechforum.eu/
• SFDA: Webinar Clinical Evaluation and PMCF: https://www.sfda.gov.sa/en/workshop/86686

GUIDANCES

• MDCG Subgroup development and deliverables – https://ec.europa.eu/health/system/files/2022-04/mdcg_ongoing_guidancedocs_en.pdf
• MDCG 2022-5 Borderline: https://ec.europa.eu/health/document/download/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en_0.pdf
• WHO Guidance: PMS for MD and IVD. https://www.who.int/publications/i/item/9789240015319

NOTIFIED BODIES:

• IVDR: 3EC international. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3

Easy Medical Device Nostalgia:

• Episode 175: How to prepare an audit with Front Room Back Room: https://podcast.easymedicaldevice.com/175/
• Episode 176: How your PMCF is evaluated by a Notified Body with Matthias Fink from TÜV SÜD: https://podcast.easymedicaldevice.com/176/
• Episode 177: Training process with Rod Beuzeval and Katie Cooney from Trinzo and Meddev Solutions: https://podcast.easymedicaldevice.com/177/

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

The training process can create a lot of non-conformances during audits and this is why we will try to explain to you how to avoid that. Rod and Katie from Trinzo will be helping us to create a compliant training process. We will talk about internal training and also training organized by external companies. We will discuss the way an auditor can find some of the issues. The effectiveness monitoring will also be important to cover. So don’t miss this episode of the podcast.

Who is Rod Beuzeval?

Rod is a regulatory expert with 24 years’ experience in regulated pharmaceutical and medical device companies and holds a RAPS RAC Global scope certification. Rod develops and routinely delivers training on EU MDR,EU IVDR, MDSAP, ISO 13485, risk management, clinical evaluation and provides consultancy on projects within this realm.  Throughout Rods career, he has worked with many medical device and IVD companies, helping them to achieve and maintain compliance. With both industry and notified body experience Rod is able to understand what exactly is needed and how to implement it in an effective manner.

Who is Katie Cooney?

Katie is the Training Centre of Excellence Lead at Trinzo She has over 15 years of experience in a variety of training roles and has performed these roles across all levels of the business. Her experience has been gained within Multinational Manufacturing including Medical Device, Pharmaceuticals and Automotive.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

Links from the Video

• Rod LinkedIn: https://www.linkedin.com/in/rod-beuzeval-rac-00452317/?originalSubdomain=uk
• Katie Linkedin: https://www.linkedin.com/in/katie-cooney-08ab7061/?originalSubdomain=ie
• Meddev Solutions Website: www.meddevsolutions.co.uk
• Trinzo Website: www.trinzo.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.