Easy Medical Device Podcast

► Webpage: https://podcast.easymedicaldevice.com/33

As we are changing the Medical Device rules, we need to certify new Notified Bodies in Europe. With the new MDR 2017/745 and IVDR 2017/746, all Notified Body should apply for new accreditation.

But apparently, this new regulation is not so easy and many Notified Bodies decided to not apply first. Then we have Notified Bodies that applied but decided to Lay Down Service (LRQA, UL, Intertek, QS Zurich…).

• So what are the consequences for Manufacturers that have a certificate with these Notified Bodies?
• What should they do to continue the business?
• Is there something the member states can do to help them?

Erik Vollebregt, from Axon Lawyers, will help to answer those questions. He will tell you exactly what you should do and also what are the consequences for your business. We will also add Brexit on the equation to see if this can be worst.

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 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 national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as 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 about Erik:

He 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.”

Links from the Video

• Erik Vollebregt blog: https://medicaldeviceslegal.com
• Linkedin Profil: https://www.linkedin.com/in/erikvollebregt/
• Twitter Meddevlegal: https://twitter.com/MedDevLegal
• Axon Lawyers: https://www.axonlawyers.com/
• Previous episodes with Erik: https://podcast.easymedicaldevice.com/14
• UL Notified Body information: https://www.raps.org/news-and-articles/news-articles/2019/7/ul-uk-to-sunset-operations-under-eus-medical-devi
• LRQA Notified Body Information: https://www.raps.org/news-and-articles/news-articles/2019/6/uk-nb-will-not-apply-for-eu-mdrivdr
• QS Zurich Information: https://www.medtechdive.com/news/swiss-notified-body-to-exit-sector-heightening-eu-capacity-fears/557160/
• Intertek information: https://pharmaintelligence.informa.com/resources/product-content/notified-body-capacity-team-nb-members-way-ahead-but-picture-clouded-by-brexit

Social Media to follow

■ Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

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

The post Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

One important piece of the puzzle for the new Medical Device Regulation is about Notified Bodies. More and more we receive the information that some of them decide to Lay Down Service. What are the consequences for manufacturers? What is a solution for them? Erik Vollebregt will be my guest on this episode. The post Episode 33 – Notified Bodies Lay Down Service with Erik Vollebregt appeared first on Medical Device made Easy Podcast.

In the Middle East, there are also some opportunities to market your Medical Devices and today we will talk specifically about Pakistan. Muhammad Sohail who is specialized in Pakistan Market will share with us more information and help us to register your products.

He will first describe the Pakistan market with some numbers and also the products that are currently imported. Then he will explain the different steps you’ll have to follow to register your medical device.

As there was an update on the regulation, it’s now easier to register your products. Muhammad Sohail accepted also to prepare a package of documents so you can already see what are the requirements. You can download them on the links section.

Who is Muhammad Sohail?

He is a successful and highly experienced professional, holding a degree of pharmacy. His experience of more than eight years combines extensive regulatory expertise of handling regulations of medical devices, drugs, biologicals, and alternative medicines.

He has also been appointed as Industry (Secondary) representative of Asian Harmonization Working Party (AHWP) by the Drug Regulatory Authority of Pakistan.

Links

• Muhammad Sohail Linkedin: https://www.linkedin.com/in/muhammad-sohail-2955332b/
• Securities and Exchange Commission of Pakistan: https://www.secp.gov.pk/
• Package documents Pakistan Registration: https://mailchi.mp/easymedicaldevice/pakistan-registration

https://www.youtube.com/embed/PrqoJfJHw3s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 32 – Pakistan Registration Process with Muhammad Sohail appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

Pakistan Registration requirements for Medical Devices have been improved and leave more opportunities for Manufacturers. Muhammad Sohail, will share with us the situation of this market and the steps to register your products. The post Episode 32 – Pakistan Registration Process with Muhammad Sohail appeared first on Medical Device made Easy Podcast.

You decided to move to Regulatory Affairs, but you don’t know where to start. Then this is the right episode for you. Because I met with Karandeep Singh Badwal and he experienced the same situation.

Karandeep will describe 3 ways to approach Regulatory Affairs. He described that also on a Cheat Sheet that you can download here.

One important thing to summaries the discussion is for you to open a LinkedIn account and really connect with people. Don’t hesitate to contact me also, I would be happy to connect with you.

Who is Karandeep Badwal?

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.

Links from the episode

• Karandeep LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/
• A cheat sheet of the episode: https://podcast.easymedicaldevice.com/wp-content/uploads/2019/07/Your-First-Job-In-Regulatory-Affairs.pdf
• Medical Device Webinars: https://school.easymedicaldevice.com/courses-2/
• Episode 21 – Master Regulatory Affairs: https://podcast.easymedicaldevice.com/21
• Episode 10 – Understand MDSAP: https://podcast.easymedicaldevice.com/10
• Episode 14 – Update MDR and IVDR: https://podcast.easymedicaldevice.com/14
• TOPRA: https://www.topra.org/
• RAPS: https://raps.org
• Easy Medical Device Linkedin Group: https://www.linkedin.com/groups/8667959

https://www.youtube.com/embed/13mfUfR6uGI?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 31 – First Regulatory Affairs Job with Karandeep Badwal appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

Finding your first Regulatory Affairs Job can be a challenge. And Karandeep Badwal knows about that as he followed this journey. He is now Regulatory Affairs Contractor. Karandeep wanted to share with the audience some tips to be able to find quickly your first job. So don't miss those actionable tips. The post Episode 31 – First Regulatory Affairs Job with Karandeep Badwal appeared first on Medical Device made Easy Podcast.

Episode 30 – FDA Promotional Compliance with Darshan KulkarniPodcast Episode 30 – FDA Promotional Compliance with Darshan Kulkarni

The topic of Promotional Compliance is really important in the USA. As you will hear on this episode, advertisement is everywhere and most importantly, the advertisement for Healthcare Products.

So to keep this topic safe, some rules are important to respect. And to explain that to us, I invited Darshan Kulkarni, Principal Attorney at the Kulkarni Law Firm. He will tell us what should be done to avoid to receive some non-pleasant letters from the FDA.

Who is Darshan Kulkarni?

Darshan is an attorney and pharmacist, and provides legal and regulatory advice to drug and device companies and their service providers including advertising agencies, and medical writing agencies. His services include reviewing and discussing privacy concerns, promotional review services for websites and sales pieces, and responding to titled and untitled letters. 
  He has previously served as VP of Regulatory Strategy and Policy for a global consultancy and has lectured in engineering, medical, and law schools all over the country. He currently teaches a course on the Promotion of Biomedical Products at the Univ. of the Sciences, serves on various editorial and advisory boards including serving as the current Chair for the American Bar Association’s Life Sciences Interest Group, and has written multiple book chapters on the promotion of medical products. 

Links from the Podcast

• Youtube Channel: https://www.youtube.com/channel/UC-HtL8mAonEPWZskP52xbQQ
• Law firm website: https://www.kulkarnilawfirm.com
• Darshan Podcast: https://www.darshankulkarni.com/
• Twitter: https://twitter.com/fdalawyers
• Darshan Linkedin profile: https://www.linkedin.com/in/darshankulkarni

https://www.youtube.com/embed/POsgO_T1Jys?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The post Episode 30 – Promotional Compliance with Darshan Kulkarni appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

The topic of Promotional Compliance is really important in the USA. As you will hear on this episode, advertisement is everywhere and most importantly, the advertisement for Healthcare Products. The post Episode 30 – Promotional Compliance with Darshan Kulkarni appeared first on Medical Device made Easy Podcast.

Episode 29 – 5 Steps to create your QMS with Jason LimPodcast Audio Episode 29 – 5 Steps for a QMS with Jason Lim

The creation of a Quality Management System or QMS is a journey. Some companies consider that only as a formality to check the box and are able to sell medical devices. Others are really considering that as a tool for a long term journey.

To help Medical Device companies on this Journey, I have invited a Medical Device Expert on Quality Management System creation, Jason Lim which is the CEO of Stendard.io.

He will reveal to us his 5 step strategy to create a QMS and get certified. These steps seems obvious but you will see that some are stopping at step 1 and then fail.

Who is Jason Lim?

Mr Jason Lim has been a strong advocate of standardisation,starting off his career as a regulator in Singapore’s HSA and later on as aquality manager of a MedTech accelerator. His venture as an entrepreneurstarted off as a Quality and Regulatory Consultant and have worked with manyMedTech companies across different device focus and classification. He alsoparticipates in an international working group and contributes to thedevelopment of world-class standards. He strongly believes that utilising technologiescan further help more companies in implementing international standards,streamline business processes across the organisation and accelerate globalgrowth. Stendard was born and the vision is to put quality at the centre ofbusinesses and make it easier.

Today, more than 200 companies in the MedTech and Food industries from Korea, Germany, Australia, India and Singapore are successfully using Stendard Solution as part of their ISO certification, saving time and money. 

Links

• Stendard website: https://www.stendard.io/
• Free test Stendard: https://first.stendard.io/register
• Jason Lim Linkedin: https://www.linkedin.com/in/jasonstendard/
• Article FAQ ISO 13485: https://easymedicaldevice.com/faq-iso-13485/

https://www.youtube.com/embed/jquSG6TV_g0?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

Test of STENDARD

I wanted to test Stendard and see if I can create a QMS within 30 Minutes. Check if I reached the goal.

https://www.youtube.com/embed/dynWTdnYM6A?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

My Challenge – Create a Quality Management System in 30 Minutes

The post Episode 29 – 5 Steps to create a QMS with Jason Lim appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

Jason Lim will reveal to us what are the 5 steps to create a good Quality Management System or QMS. The post Episode 29 – 5 Steps to create a QMS with Jason Lim appeared first on Medical Device made Easy Podcast.