Easy Medical Device Podcast

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In this episode of the Medical Device made Easy Podcast, Monir El Azzouzi, and Stefan Bolleininger are helping you to create your quality management system with the objective to be compliant to EU MDR 2017/745 or EU IVDR 2017/746 Now even class I devices should have a Quality Management System, but:

• Should you apply to ISO 13485?
• Is it mandatory?
• Do you need to contact a Notified Body or are there other options?

We will help you by providing a step by step understanding on how to get a Quality Management System. We will also help you understand the audit process.

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 Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.

Links

• Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
• Be-on-quality: https://be-on-quality.com
• 5 Steps to create a Quality Management System: https://easymedicaldevice.com/5-steps-quality-management-system/
• ISO 13485 standard: https://bit.ly/368Xvl0
• Frequently asked questions on ISO 13485: https://easymedicaldevice.com/faq-iso-13485/

The post How to create a QMS compliant to MDR with Stefan Bolleininger appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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MDR is requiring to create a Quality Management System but how to do that. This is what you will learn with Monir El Azzouzi and Stefan Bolleininger. The post How to create a QMS compliant to MDR with Stefan Bolleininger appeared first on Medical Device made Easy Podcast.

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510k is a famous way to register your Medical Devices in the US. It is so famous that even if you don’t need it, you will ask to go through it. In this episode, Michelle Lott, Founder, and Principal at LeanRAQA will help us understand everything about 510k. And she is also providing a Slide deck to help you understand all about the FDA process.

We will discuss the different types that are existing:

• Traditional
• Abbreviated
• Special

We will also discuss the way to use standards to confirm that your product conforms to the regulation. Similar to the Harmonized Standards used in Europe.

On a different note, Michelle will explain to the audience participation in the MDG Premium. This is a group where Medical Device experts, manufacturers, service providers are part of.

Who is Michelle Lott

Michelle Lott is the founder and principal of leanRAQA, which has supported 100+ companies with regulatory strategy, regulatory submissions, quality systems compliance, FDA audits, due diligence, technical support services – (and grief counseling, because dealing with regulators can be emotionally draining!).

She has served on the FDA Device Good Manufacturing Practices Advisory Committee and is a vocal advocate of EU MDR readiness. Michelle serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries.

She has a weakness for tequila and anything barbecued.

Links for this episode

• Michelle Lott Linkedin: https://www.linkedin.com/in/michellelottraqa/
• LeanRAQA website: https://leanraqa.com/
• Download 510k Presentation: https://mailchi.mp/easymedicaldevice/510k-presentation
• MDG Premium website: https://www.medicaldevicesgroup.net/premium/
• FDA 510k process: https://www.fda.gov/medical-devices/premarket-notification-510k/510k-forms
• Substantial equivalence blog post: https://easymedicaldevice.com/substantial-equivalence-on-a-fda-510k-process-how-to-demonstrate-it/
• Episode 43 – FDA Registration: https://podcast.easymedicaldevice.com/43/

The post How to register your Medical Device through 510k with Michelle Lott appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Michelle Lott is my guest and will help us understand the 510k registration process with the US FDA. Should you use it? Is this changing? Learn everything in 1 episode. The post How to register your Medical Device through 510k with Michelle Lott appeared first on Medical Device made Easy Podcast.

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A supplier audit is a difficult task that really needs to be well understood. With the new Medical Device Regulation EU MDR 2017/745, there is a specific requirement that Medical Device Manufacturers should have better control of their suppliers.

I always hear that as soon as the supplier is ISO 13485 it is sufficient for the manufacturers, but this is not really answering the question if your product is manufacturers following your specification…

So I propose to more focus on product specification instead of ISO 13485 requirements. Check the discussion I have with Stefan Bolleininger from Be-on-Quality

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 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 a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company 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, Podcast, Online courses.

Links from the Video

• Stefan Bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
• Using audits to improve supplier performance: https://www.mddionline.com/using-audits-improve-supplier-performance

The post Medical Device School: How to audit your Suppliers? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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How should you audit your suppliers? Should you do the same as a Notified Body? Monir El Azzouzi and Stefan Bolleininger are providing you their opinion. The post Medical Device School: How to audit your Suppliers? appeared first on Medical Device made Easy Podcast.

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PMCF or Post-Marketing Clinical Follow-Up is a cornerstone of the Medical Device Regulation 2017/745.

This is why I took the opportunity to ask some questions about it to Helene Quie from Qmed Consulting. I met Helene at Medica 2019 in Dusseldorf and she accepted to help the audience to have a better understanding of PMCF.

Helene was part of the podcast episode 40 where we discussed Clinical Evaluation Reports or CER and specifically about the way to prove the equivalence between devices.

PMCF is part of this big box that is PMS or Post-Market Surveillance and this can be a good strategy to start one so you can collect data from the market and use them to prove that your products continue to be safe. This is more important for products that are transitioning between MDD and MDR and which do not have data available.

Who is Helene Quie

CEO at Qmed-consulting – experts in creating value-based documentation for innovative medical devices getting access to the markets through strong and honest partnerships with our clients.

It is my vision to enable better health through close collaborations with large established or newly started medical device manufacturers, small venture based innovative companies, venture funds, notified bodies, hospital, doctors and nurses within a wide range of medical device products and concepts from high-risk complex products such as heart valves with biological tissue to lower risk class products such as dental care products.

I believe that we through our trusted partners and colleagues can change the treatment of sick patients – making sure frontier products reach the patients and end-users, saving patient’s lives.

Together with the Qmed team, I have provided advice and/or operational services for several clients since 2006 within clinical and regulatory affairs, quality management, reimbursement, and health economics and market access with presence through our Qmed team and trusted partners in Europe, US, Canada, India, and Australia. 

Links to this episode

• Helene Quie Linkedin: https://www.linkedin.com/in/helene-quie-863a323/
• Qmed Consulting: http://www.qmed-consulting.com/
• MEDICA Video: https://youtu.be/bBC2TwL6HFo
• Episode 40 – CER product equivalence: https://podcast.easymedicaldevice.com/40
• Easy Medical Device Youtube Channel: youtube.com/c/EasyMedicalDevice?sub_confirmation=1

The post Post-Marketing Clinical Follow-up with Helene Quie (PMCF) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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PMCF is a key element of the Post-Marketing Surveillance process. As there were a lot of questions about it then I decided to ask Helene Quie some questions while I was at Medica 2019. The post Post-Marketing Clinical Follow-up with Helene Quie (PMCF) appeared first on Medical Device made Easy Podcast.

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This is the last episode of 2019. Episode 56 is a celebration of all that was accomplished during this year. I wanted to review some topics that were discussed and thank some of the people that were part of it.

The Year 2019 will be my Podcasting Year as it’s been 1 year that I started this podcast and I am really proud of its success. I will also celebrate the people that were part of it. I received some great guests and this was really a success for me. I was able to convince some people that I was admiring to come and get interviewed by me. Imagine that you are following a person and that now you are able to ask this person important questions. I feel really lucky.

I will also talk about some personal things that happened to me as I moved from employee to entrepreneur. I am now my own boss and this is so great. I can do what I want without asking the authorization.

I will also mention the future of Easy Medical Device. And I hope you will be part of it. I really appreciate to serve you and want to continue if you authorize me.

2020 will be a year with a lot of challenges and events. For 2 years I am talking about May 2020 and this is soon now. So we will see if this will be a catastrophe or if this will be a great moment. Any way I will be here to share that with you.

I wanted to finalize this by saying Thank You for all your great messages. Don’t stop please as this motivates me. I am really happy that I was able to support a lot of you.

I want to close this by saying that I WISH YOU A HAPPY NEW YEAR and I really wish you to be happy in your life personally and professionally. This is a great feeling.

The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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This is the last episode of 2019 and I wanted to summaries the situation and introduce you to my 2020 projects. The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Medical Device made Easy Podcast.