https://www.youtube.com/embed/3i13zimtjJw?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

If you are working for Quality then you maybe experienced this situation. And if you are an employee outside of Quality then we maybe understand why you are doing that.

Monir El Azzouzi and Karandeep Badwal are discussing their experience when it is about hiding problems to the Quality Departments. They will also define the consequences of that and how this can change.

Mr. Karandeep Singh Badwal is a Regulatory and Quality Contractor specializing in medical devices, his educational background is an MSc Pharmaceutical Quality by Design, however, has worked almost exclusively within the medical devices industry from multinational companies to startups since his graduation.

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…

• Karandeep Badwal LinkedIn Profile: https://www.linkedin.com/in/karandeepbadwal/

The post Medical Device School – Why are Staff hiding problems to QA & RA? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/x-MZElb-ur0?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

This episode will be really interesting for the pharmaceutical companies that are producing Drug-Device combination products as it explains the consequence of EU MDR Article 117 for their products.

For all projects that are ongoing, you need to consider the new requirements coming from EU MDR as this is amending the 2001/83/EC Medicinal Product Directive.

Theresa Jeary will be my guest during this episode, and her experience with Drug-Device products and as a former Notified Body assessor will help you understand what are the deliverables you should provide now.

We will also discuss the importance of the Notified Bodies during this process as the pharma industry is not really used to deal with this kind of third party entity.

Finally, Theresa prepared a document that you can download below. It will provide you with a summary of the situation for Drug-Device combination products when it comes to the EU MDR.

Theresa has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has been involved in the development of many commercially available medicinal and medical device products.

Theresa has over 12 years of Notified Body experience, initially at BSI as a technical expert for devices with ancillary medicinal substance and she held the position of Head of Notified Body at the UK NB LRQA until January 2019.

Her core area of technical expertise is in the combination product area and Theresa now works as a consultant to the Pharmaceutical and Medical device sectors supporting Companies in meeting regulatory requirements. Theresa is a frequently invited speaker on the medical device legislation and combination products.

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…

• Theresa Jeary LinkedIn Profile: https://www.linkedin.com/in/theresa-jeary-09bb7226/

The post MDR & Drug-Device Combination Products with Theresa Jeary appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/XDN1PoDveuQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this episode of the Podcast, I will provide you with the situation for the month of march 2020 and what should happen next.

As you may know we are in the beginning of a pandemic and this is really a stressful situation for all countries worldwide. So this episode will also show you some elements that should be interesting for you to know during this period.

We will also discuss about the Notified Body Situation. There is a new Notified Body that was announced but this is not enough. We need more. Let’s see the numbers.

I will also list the MDCG guidances and regulatory updates that were released.

Finally, we will review what happened at Easy Medical Device during that month.

Don’t miss the links with all the source of information

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…

• Coronavirus
  • DoA delay 1 year: https://audiovisual.ec.europa.eu/en/video/I-187348

The post Medical Device News – March 2020 Review (EU MDR) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/lzpJnvN5FoM?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

This is a topic that all of you are talking about. What is a Significant Change to your Medical Device?

I may say, it depends and this is also the answer of Erik Vollebregt who is my guest in this episode of the Podcast.

He will help us understand what you should consider a Significant Change and also provide some examples like for Software companies or also for a change of suppliers or finally during a Merger and Acquisition.

Why is this is so important? Because this would have an impact on your transition period. If you have an MDD certificate that expires after May 26, 2020, then you can benefit from a transition period where you can still supply your medical devices even if they have not transitioned to EU MDR.

But if your device is having a Significant Change during this period, then the transition period stops for it. It immediately falls under EU MDR. So it is important for Medical Device Manufacturers to understand this concept and plan a strategy for it.

After the recording of this episode, the MDCG finally released the guidance expected. I put the link below. This is based on some documents that we discussed during this episode. All that was covered in this episode is not changed due to this guidance.

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.”

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…

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

The post What is a Significant Change for your Medical Device? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

https://www.youtube.com/embed/y4mW9KdAuU8?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

We already talked on the podcast about the class I devices. But here I wanted to focus more on the sub-classes of class I products. There are 3 sub-classes which are Class I sterile (Is), Class I with a measuring function (Im) and the new Class I for surgical reusable devices (Ir). When class I products are Self-Certified, you should know that this is not the case for class I special devices.

Elem Ayne from ACR Medical will help us understand the difference and what should be done to have compliant medical devices. She will also tell you what will be checked during an audit. This part is really important. Don’t forget also to download the presentation that Elem prepared for you.

Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of “DM Experts” network (in France). She has started her career in R&D in microbiology, oncology, and biochemistry.

She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality and regulatory affairs for different industries, in particular in sterilization.

She has finally specialized herself in Regulatory affairs working especially in Class I reusable granted by a Master’s degree in this field before founding her own company “ACR Medical” to support manufacturers in their compliance with MDR (EU) 2017/745.

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…

• Elem Ayne LinkedIn profile: https://www.linkedin.com/in/elemayne/

The post All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi