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Clinical Investigation is one of the toughest process within the EU MDR 2017/745. If you have to perform one for your Medical Devices then it can be a long and expensive process.

In this episode, Helene Quie from Qmed Consulting, will help us understand how to perform it in a good way. This episode will answer some of the questions you have about Clinical Investigation and we hope this will make more clarity for you.

Some of the questions answered are:

• Which products do need a clinical investigation?

Don’t hesitate to go below check the links on the different guidance.

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. 

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with a 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

• Helene Quie Linkedin Profile: https://www.linkedin.com/in/helene-quie-863a323/

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We talked a lot about the regulatory requirements for your Medical Devices. Now let’s talk about something more technical which is the Biological Evaluation following ISO 10993-1 or also called Biocompatibility.

This is something that is key for the Medical Device Manufacturers but it is also not well understood. So Ana Luiza Cassin Duz, a Clinical Specialist for Medical Devices is helping us. She will answer all my questions on Biological Evaluation and I am sure there is something that will surprise you.

Don’t hesitate to ask your questions in the comments.

She holds a Bachelor’s Degree in Biological Sciences, a Master’s Degree in Cellular Biology, a Ph.D. in Biological Sciences, and an MBA in Quality Management.

She has worked for the past 10 years in the quality, regulatory and clinical evaluation of various types of medical devices, such as Biological Heart Valve, Endoprosthesis, Inorganic valved conduit, Annular Rings; as well as, Extracorporeal circulation machine, Defibrillator, Cardioverter, and Patient monitors; in addition to Intrastromal corneal ring, Intraocular lens, and Contact lenses.

Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with a 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 has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses…

• Ana Luiza Cassin Duz Linkedin Profile: https://www.linkedin.com/in/ana-luiza-cassin-duz-clinical/

The post How to perform a Biological Evaluation for your Medical Device? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Ok, this month the EU MDR is LIVE so we will talk about that. The date of application for EU MDR 2017/745 was May 26th, 2021 and there is a lot of information that I will share with you.

We will talk about

• EU MDD bye bye party

HOT TOPICS

• Portugal Inframed: https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/4404079

SWIXIT

• Revision of the Medical Device Legislation: https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html

TURKXIT

• Team NB Letter to MDCG: https://www.team-nb.org/wp-content/uploads/2021/05/MDCG-Update_EU-Turkey-Customs-Union-Medical-Devices.pdf

IVDR 2017/746

• IVDR: TEAM NB – CA for class D devices https://www.team-nb.org/wp-content/uploads/2021/05/Team-NB-PositionPaper-ClassD-20210519-V4.4.pdf

Standard and Guidance

• MDCG 2021-09 – MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers

EASY MEDICAL DEVICE

• FDA: Is the Emergency Use Authorization worth it? Michelle Lott https://podcast.easymedicaldevice.com/127/

The post Medical Device News – June 2021 Update [EU MDR Date of Application] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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Last year we had reviewed the result of the EU MDR Survey made by Climedo and this year we check the difference. Do you think that there will be a big change?

Climedo has decided to ask questions related to the EU MDR but also to the context due to Coronavirus. So we are now looking at the result and you’ll see that there are some changes. But still the same on some of the most important topics.

Check below for the link on the last survey and this year’s one.

Catherine started her career in the SaaS field in Corporate Communications for a B2B online language training company where she managed the company’s global marketing and PR activities. After almost four years, she switched to strategy consulting firm Oliver Wyman to help drive the company’s digital marketing and employer branding mission within Europe. In 2019, she joined Climedo Health, a software company that helps MedTech companies collect clinical data on their medical devices with the help of cloud-based solutions. As a bit of a “newbie” to the healthcare sector, she has enjoyed the steep learning curve offered by the startup world and creates regular content to help educate MedTech companies on matters such as electronic data capture and the EU MDR. She also carries out market research to assess the state of the industry in terms of MDR preparation and costs. Catherine studied Modern Languages (French and Spanish) at Newcastle University, followed by a Masters’s degree in Management at Warwick Business School.

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…

• Catherine Higginson LinkedIn Profile: https://www.linkedin.com/in/catherine-higginson/

The post EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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MDR is coming In 1 week and before that, I asked Erik Vollebregt from Axon Lawyers about some questions that I receive. We will talk about: – EU MDR IVDR postponement or not? – Economic Operators date of application – PRRC do we need it from day 1 – Exclusion from EU MDR – OEM OBL rules from May 26th, 2021 And Erik announces the content of its book that will be released soon. You will see on the following sections the links related to the topic we have discussed.

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 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.”

Monir El Azzouzi is a Medical Device Expert specialized 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…

• Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/

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