Easy Medical Device Podcast

https://www.youtube.com/embed/Fxc3eIPqGXA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The focused region is the region that agreed to follow the ASEAN regulation. ASEAN means the Association of South East Asia Nations.

In this episode of the podcast, Michael Wetherington will help us to have a better understanding of how to register your products in this region.

You will see that there are some differences with the fact that even if all countries are following the same directive, there can be still some differences. And also that having a Partner in the region can help you save a lot of time and money.

Fortunately, MedicalReg,com can help you so don’t hesitate to contact Michael Wetherington if you need any support. As said in this episode he proposes his service to help manufacturers that try to reach this region.

Don’t forget to check the links below to understand more about this directive.

Who is Michael Wetherington?

Michael Wetherington is the Founder of MedicalRegs.com. MedicalRegs.com helps MedTech startups design devices with the applicable requirements in mind. They go further by providing regulatory services for the EU, US, Canada, and ASEAN markets.

His background encompasses medical device R&D, accredited testing lab, and Notified Body experience. He is also a mentor at Elemed’s Mentoring Academy. And, when time permits, he likes to sing, play the drums, and the guitar.

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.

Finally, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Michael Wetherington Linkedin Profile: https://www.linkedin.com/in/medicalregsdotcom/
• MedicalRegs.com website: https://medicalregs.com
• ASEAN Directive: https://asean.org/storage/2016/06/22.-September-2015-ASEAN-Medical-Device-Directive.pdf
• Countries: https://asean.org/asean/asean-member-states/
• Best practice for Device testing with Michael Wetherington: https://podcast.easymedicaldevice.com/89/

The post How to register your Medical Device in the ASEAN region? 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.

Michael Wetherington will by your instructor in this episode. He will provide you all the information to register your product in the ASEAN region. This is the countries located in the South East Asia. The post How to register your Medical Device in the ASEAN region? appeared first on Medical Device made Easy Podcast.

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

This month on the Medical Device News section of the podcast we will talk about:

• Exits from Europe with Brexit and Swixit
• Conferences that are now mainly going virtual
• Green Belt Certification
• Celebrations
• Notified Body situation with the countdown offered by Michelle Lott
• Standards and guidances
• Podcast

Don’t hesitate to look at the Medical Device News links in the below section to review more in detail each topic.

Don’t forget also to participate in the Green Belt certificate so you can learn more about EU MDR.

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.

Recently, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

Medical Device News Hot topics:

• MHRA Guidance on Brexit: https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021
• Swiss votation on immigration: https://www.euractiv.com/section/justice-home-affairs/news/swiss-voters-refuse-immigration-cuts-eu-sees-great-future-in-relationship/
• FT News on Swiss votation: https://www.ft.com/content/eb22b826-1e37-4b98-96bf-561994eb1ee8
• Angelina Hakim LinkedIn: https://www.linkedin.com/in/angelina-hakim-34b70225/
• Episode 62 – Swixit with Ronald Boumans: https://podcast.easymedicaldevice.com/62
• Episode 63 – Brexit Swixit and Turkxit with Erik Vollebregt: https://podcast.easymedicaldevice.com/63

Conferences:

• MDG premium October 16th – Economic Operators – https://medgroup.biz/calls
• TOPRA Symposium October 6th – 8th – https://www.topra.org/sym2019

Green Belt Certificate:

• Courses: https://school.easymedicaldevice.com/emd-course/

Celebration:

• 4000k Youtube channel: https://www.youtube.com/c/EasyMedicalDevice?sub_confirmation=1

Notified Body:

• Michelle Lott LinkedIn: https://www.linkedin.com/in/michellelottraqa/
• NANDO database EU MDR 2017/745 NBs: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
• 3EC International information: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=NANDO_INPUT_175701
• NANDO database EU IVDR 2017/746 NBs: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

Standards and guidance’s:

• MDCG meetings: https://ec.europa.eu/health/sites/health/files/md_dialogue/docs/md_events_2020_en.pdf
• MDSAP audit approach: https://www.fda.gov/media/87544/download

Podcast episodes September:

• Episode 92 – Be successful at your MDR and IVDR audit with Martin Witte: https://podcast.easymedicaldevice.com/92/
• Episode 93 – How can GDPR impact Medical Devices with Erik Vollebregt: https://podcast.easymedicaldevice.com/93/
• Episode 94 – How to get some help from regulators with Cliff Bleustein: https://podcast.easymedicaldevice.com/94/
• Episode 95 – How to register ATMP-Device combination products with Margareth Jorvid: https://podcast.easymedicaldevice.com/95/

The post The latest news on Brexit, Swixit and EU MDR [Medical Device News] 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.

This month a lot of exists on the Medical Device news. We are still under a pandemic so conferences are going virtual and Easy Medical Devices has the best training for EU MDR. The post The latest news on Brexit, Swixit and EU MDR [Medical Device News] appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/qhr3P6Hnu6c?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

ATMP stands for Advanced Therapy Medicinal Products, which is a category of Medicinal Product. But if I combine this with a Medical Device, how should this be regulated and how can I register this product in Europe?

Effectively, this is exactly the question that Margareth Jorvid from Methra Uppsala AB will help us to answer. So if your product is combined with a Medical Device, you should listen to that.

Remember, we had a previous episode specifically on combined products Drug-Device but here you’ll see that the process is a bit different.

To help you understand, we will review the requirements of the 1394/2007 regulation. It contained already requirements on how to manage ATMP-device combined products.

Who is Margareth Jorvid?

Margareth Jorvid has over 30 years of experience in Regulatory Affairs and has worked at the Swedish Medical Products Agency (MPA) as well as large and small pharmaceutical and biotech companies, such as Roussel Nordiska, Hoechst Marion Roussel (in Stockholm and Paris, France) and Neopharma.

Since 2006, consultant in regulatory affairs and QA for pharmaceuticals, ATMP (cell- and gene therapies), medical devices, and combination products through her company Methra Uppsala AB, LSM group.

Additionally, she is a member and honorary member of TOPRA (Organisation for Professionals in Regulatory Affairs), previous board member, and TOPRA president from 2005-2006.

She holds a MSc Pharm from Uppsala University, a MBA from Stockholm School of Economics, Sweden, and a MSc MTRA from Cranfield University, UK.

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.

Recently, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Margareth Jorvid Linkedin Profile: https://www.linkedin.com/in/margareth-jorvid-60059440/
• EMA, Advanced Therapy Medicinal Products: https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview
• EMA, Legal framework for ATMPs: https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview
• Regulation (EC) No 1394/2007 (ATMP regulation including combined ATMP): https://bit.ly/3kSzMgQ
• ATMP Classification: https://bit.ly/3kSwnyE
• Summaries of scientific recommendations on the classification of advanced therapy medicinal products, including examples of combined ATMPs: https://bit.ly/309NHHa
• Marketing-authorization procedures for advanced-therapy medicinal products: https://bit.ly/3j8fT4S
• Procedural advice on the evaluation of combined advanced therapy medicinal products and the consultation of Notified Bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007: https://bit.ly/3cynerO
• Interview Ilya Pharma: https://www.ilyapharma.se/news-list/meet-margareth-jorvid-leading-innovations-to-products/
• Company Immunicum: https://immunicum.se/
• TOPRA Symposium 2020: https://www.topra.org/sym2019
• Podcast episode on Drug-Device combination products: https://podcast.easymedicaldevice.com/71/

The post How to register ATMP-Device combination products? 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.

ATMP is a category of product not so well known by the regulatory affairs professionals. I wanted to help you understand how they are working with Margareth Jorvid. She will provide us with a specific overview for ATMP-Device combination products. The post How to register ATMP-Device combination products? appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/ZYEsRLN83gQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

In this episode, Cliff Bleustein, President and CEO of Apos Therapy is explaining to us all the process that his company followed to place his Medical Device on the market.

One of the most important advice was to get support from the regulators. They are the most reliable source of information so you can go in the right direction. FDA is providing this possibility to meet regulators and then be able to receive some feedback. This saves time and money for the company but also to the regulators.

Cliff explains to us also the way medical device companies can get Clinical Data for its product. Learn more about Apos Therapy with the links below.

Who is Cliff Bleustein?

Dr. Clifford Bleustein is the Global President and CEO of AposTherapy. Prior to AposTherapy, Dr. Bleustein was President and CEO of Computer Task Group (NASDAQ: CTG) where he managed more than 3400 people globally and more than $340M in revenue across healthcare, technology services, energy, and financial services with operations in North America, Western Europe, and India. Dr. Bleustein went to CTG from Dell where he had several roles rising to become the Chief Medical Officer and Global Healthcare Solutions Leader with P&L responsibility for Healthcare & Life Sciences Solutions globally.

Doctor Bleustein also had a successful period as a consultant at PwC rising to Director with a diverse experience of projects including interim executive director of outpatient services, business strategy, international “biocluster” development, mergers & acquisitions, healthcare operations, physician alignment, governance, and resource optimization. On the ground experience in the UK, Ireland, India, South Africa, and China with assessments in the Middle East / Asia.

Clifford Bleustein graduated from the Medical College of Wisconsin and completed his internship at the New York Hospital Medical Center of Queens. Cliff later completed his residency in urology at Montefiore Medical Center. Then he went on to private practice Urology and became a board-certified Urologist. He has an extensive roster of peer-reviewed published research and 2 patents. Dr. Bleustein earned a bachelor’s degree in science from the University of Wisconsin, Madison. He also received an executive master’s degree in business administration from NYU Stern School of Business where he now teaches Healthcare Economics as an Adjunct Professor.

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 has 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

• Cliff Bleustein LinkedIn: https://www.linkedin.com/in/cbleustein/
• Apos Therapy Website: https://www.apostherapy.com/
• Episode 58 – How to register medical devices through 510k: https://podcast.easymedicaldevice.com/58/

The post How to get some help from Medical Device Regulators with Cliff Bleustein 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.

In this case study we will see how Apos Therapy was able to register his product in the US for certain therapy. Cliff Bleustein; President and CEO of Apos Therapy is my guest today and you'll see that for a CEO he knows a lot about regulatory affairs. The post How to get some help from Medical Device Regulators with Cliff Bleustein appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/lrox-Jq_fI4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

There were a lot of discussions about GDPR since its implementation in early 2018. But after a few years, some issues are happening and this may impact the Medical Device Industry.

The EU MDR 2017/745 articles 109 and 110 + EU IVDR 2017/746 articles 102 and 103 are talking about confidentiality and data protection. This means that medical device manufacturers should also follow GDPR.

Recently there was a judgment (SHREMS II) about data protection with Facebook. And even if Facebook’s act is not specifically related to Medical Devices, this judgment is impacting Medical Device companies.

In this podcast, I have invited our preferred lawyer Erik Vollebregt to help us understand the technical aspect of this judgment and what should Medical Device manufacturers do to continue to stay compliant.

Erik also prepared for you all the documents related to this judgment and the AXON lawyer Newsletter so you have all the details on hand. Download them from the links below.

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, 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.”

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

• Erik Vollebregt LinkedIn Profile: https://www.linkedin.com/in/erikvollebregt/
• Axon Lawyer website: https://www.axonlawyers.com/
• Download documents on SHREMS II: https://mailchi.mp/easymedicaldevice/episode_93
• Shrems II judgment blog post: https://medicaldeviceslegal.com/2020/07/23/the-eu-courts-schrems-ii-judgement-urgent-revisiting-of-international-personal-data-transfer-mechanisms-required/
• RAPS convergence: Economic Operators Under MDR Tuesday, September 15: https://www.eventscribe.com/2020/RAPS/agenda.asp?pfp=FullSchedule)
• MDR/IVDR Implementation, is the glass half full? with Michel Marboeuf and Oliver Bisazza at Advamed Medtech Conference 6 October 15:30 EDT https://medtechvirtual2020.pathable.co/agenda#/?limit=20&searchByComparators[0]=&searchByDisjunctives[0]=false&searchByEncoding[0]&searchByFieldKeys[0]=searchAll&searchByFields[0]=searchAll&searchBySpecial[0]&searchByValues[0]=vollebregt&sortByFields[0]=startsAt&sortByOrders[0]=1
• GDPR for MDR application with Jovan Stevovic: https://podcast.easymedicaldevice.com/44/

The post How can GDPR impact Medical Devices 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.

GDPR is not specific to medical devices, but any judgment that is issued can impact devices. And this is the case with the SHREMS II case. Erik Vollebregt accepted to answer my questions on this technical topic to help us understand how to remain compliant. The post How can GDPR impact Medical Devices with Erik Vollebregt appeared first on Medical Device made Easy Podcast.