Easy Medical Device Podcast

https://www.youtube.com/embed/Oa7jwL-HxgI?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

If you are preparing for your EU MDR 2017/745 or IVDR 2017/746 audit, then this episode is for you.

I have invited Martin Witte from TÜV SÜD to provide some tips or highlights on what a Notified Body is expecting to see during an audit. Who better than a Notified Body to tell you what you should do.

We will discuss:

• Contacting the Notified Body and planning the audit
• What is expected to see within your Quality Management System?
• How your technical files will be reviewed? – The situation with the Coronavirus and on-site audits

Martin will also be a Speaker at TOPRA Symposium 2020.

Who is Martin Witte?

Martin Witte is Senior Director Strategic Business Development at TÜV SÜD and responsible for the focus topics Active Medical Implants, Cardiovascular, Orthopedic, and Functional Safety/Software.

Prior to his current role, Martin worked as a Lead Auditor, Product Specialist in TÜV SÜD from 2014 on, and took over business development activities with his role as the head of the Active Implants business in 2016. Prior to his roles in TÜV SÜD, Martin was a Regulatory Affairs Manager at BIOTRONIK, Berlin focusing on heart rhythm management devices and on MRI safety of such devices.

His background is Biomedical Engineering which he studied in Hamburg.

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

• Martin Witte LinkedIn: https://www.linkedin.com/in/martin-r-witte/
• TÜV SÜD Notified Body page: https://www.tuvsud.com/en
• Audit preparation: https://easymedicaldevice.com/medical-device-audit/
• MDCG 2020-14 guidance: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-14-guidance-mdsap_en.pdf
• MDCG 2020-4 guidance: https://ec.europa.eu/docsroom/documents/40705/attachments/1/translations/en/renditions/native
• TÜV SÜD application form: https://bit.ly/3i2Ahnl
• MDSAP audit preparation: https://easymedicaldevice.com/mdsap/
• Episode 77 – Notified Body situation: https://podcast.easymedicaldevice.com/77/
• TOPRA Symposium 2020: https://www.topra.org/sym2019

The post Be successful at your MDR and IVDR audit with Martin Witte 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 audit for a Medical Device company can be a real struggle if this was not correctly prepared. If you want to understand what a Notified Body is looking for when it is coming to your company, then you should listen to Martin Witte from TÜV SÜD. Who better than a Notified Body to tell you what a Notified Body wants to see. The post Be successful at your MDR and IVDR audit with Martin Witte appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/bTdE2Wrlzts?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The Medical Device industry is still moving a few steps forward to EU MDR 2017/745. Here is the agenda of this review:

• UDI
• Cardiac Implantable Electronic Devices (CIED)
• Rolling plan (EUDAMED + Reprocessing of single-use devices)
• Green Belt Certificate (New session in French)
• Notified Body Situation
• New guidance and Standards
• Review of the podcast episodes

In this version, the VIDEO PARODY CLIP was blurred as there are some copyrights to the USA.

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 Hot Topics

• UDI FAQ: https://ec.europa.eu/docsroom/documents/42641?locale=en
• CIED guidance: https://ec.europa.eu/docsroom/documents/37283
• Rolling Plan of August: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.xlsx
• Regulation 2020/1207 Reprocessing of single-use devices: https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj
• Green Belt Certificate: https://school.easymedicaldevice.com

Notified Bodies

• DQS MED notified Body: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=308392&version_no=9

New Guidance and Standards

• ISO 14155:2020 Clinical Investigation: https://www.iso.org/standard/71690.html
• LinkedIn Post Helene Quie: https://www.linkedin.com/pulse/revision-iso-14155-available-helene-quie/
• MDCG 2020-14 – MDSAP report: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-14-guidance-mdsap_en.pdf
• MDCG 2020-15 – Eudamed Actor Module: https://ec.europa.eu/health/sites/health/files/md_sector/docs/2020-15-position-paper-actor-registration-module_en.pdf

Podcast

• Episode 88 – IEC 60601 with Leo Eisner https://podcast.easymedicaldevice.com/88
• Episode 89 – Medical Device Testing with Michael Wetherington https://podcast.easymedicaldevice.com/89
• Episode 90 – Virtual Conferences with TOPRA https://podcast.easymedicaldevice.com/90
• TOPRA symposium: https://www.topra.org/sym2019

The post Medical Device News – August 2020 Review (Monir El Azzouzi) 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 episode we will talk about the UDI FAQ, the new regulation for reprocessing of single use devices, the EUDAMED actor module, the new Guidances released... A lot to discuss today. The post Medical Device News – August 2020 Review (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast.

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

This year is a particular one for the Medical Device Industry and for the world. The pandemic changed completely our way to do things. What was difficult before seems to be the norm now. During the lockdown, a lot of people had to work from home which was something not realistic before. And the healthcare industry was in the front with all the masks, COVID tests… Due to the pandemic, there was also the delay of the EU MDR 2017/745 implementation.

Another thing changed. The way to participate in a conference. And today we will talk with Kevin Pay Chief Executive of TOPRA and Raluca Radu Regulatory intelligence and Symposium Manager. They will share with us about the transition from a face-to-face event to a virtual conference.

When before they had to look for a Hotel Conference room, catering company,… now they should find a good IT company to support a virtual event platform and fix connection bugs… We will see how they’ve tried to help the participant, speakers, and exhibitors to still get most of the experience. This will be really a change in the way to participate in the TOPRA symposium.

If you want to get that experience don’t hesitate to subscribe now on the page link below. Check on the links below the video of last year.

Who is Kevin Pay?

Kevin has worked at director level in both the commercial and charity sectors for the last 15 years, including many years in pharmaceutical packaging (GMP) and at Imperial College Healthcare Charity, before joining TOPRA. Kevin leads the executive team and is accountable for the strategic direction and business plans. He has overall accountability for performance against agreed objectives and risk management across the organization.

Who is Raluca Radu?

Raluca is responsible for ensuring the most relevant topics are covered in TOPRA’s annual meeting plan. She coordinates roundtables, conferences, and the Annual TOPRA Symposium, with a particular focus on programme development, managing the relationship between the working parties, the TOPRA Office, and regulatory authorities. Raluca is a pharmacist by training and has a keen interest in regulatory and health policy, as well as education. Before she joined TOPRA she worked in the Public Engagement and SME Office of the European Medicines Agency.

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…

Link

• Kevin Pay LinkedIn: https://www.linkedin.com/in/kevinpay/
• Raluca Radu Linkedin: https://www.linkedin.com/in/raluca-radu/
• The TOPRA Symposium page: https://www.topra.org/sym2019
• Video made at TOPRA Symposium 2019: https://youtu.be/bXAjqj6nikA
• TOPRA Symposium 2020 Program for Medical Devices: https://bit.ly/33uiSxN
• Podcast Episode 39 – Networking at an event with Lynda Wight: https://podcast.easymedicaldevice.com/39/

The post How to switch quickly to a Virtual Conference with TOPRA 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.

Kevin Pay and Raluca Radu from TOPRA are helping us to understand how a virtual conference can bring the same type of experience as a normal one. This year the TOPRA Symposium will be virtual so you can assist to it without to travel. Let's listen how this will be organized, The post How to switch quickly to a Virtual Conference with TOPRA appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/GJVCKwTl1e4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

When you are trying to develop a Medical Device, there is a stage that you cannot avoid which is testing your products. For that, I have invited Michael Wetherington from MedicalRegs.com who will help us understand how to prepare for it. We will also help you understand the way you need to follow to choose your Laboratory.

Tests should be done in a lab but also internally. You should test as much as possible to see if you are in the right direction. We will talk a lot about IEC 60601 as an example but other tests can be mentioned.

Michael will also provide information regarding accredited laboratories. This is not really a guarantee of quality and you should be monitoring them. The labs are providing you with a service so don’t just rely on them to perform the right tests as you know the products better than them.

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. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

Links

• Medical Regs Website: https://medicalregs.com
• Michael Wetherington LinkedIn: https://www.linkedin.com/in/medicalregsdotcom/
• US Accreditation website: https://www.osha.gov/dts/otpca/nrtl/nrtllist.html
• How to find your certification body? https://easymedicaldevice.com/accreditation-certification-body/
• Episode 88 – IEC 60601 with Leo Eisner: https://podcast.easymedicaldevice.com/88

The post Best practice for Device Testing with Michael Wetherington 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.

Medical Device Testing is something all medical device manufacturers should perform. How can you prove that your device is safe and performing without that. So now how to do it? Michael Wetherington from Medical Regs will be my guest on this episode of the podcast. He will share with us all best practices. The post Best practice for Device Testing with Michael Wetherington appeared first on Medical Device made Easy Podcast.

https://www.youtube.com/embed/V1n1FhYfzRU?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 Medical Device made Easy Podcast, I have invited Leo Eisner from Eisner Security Consultants to help us understand the standards IEC 60601 series.

Leo is an expert for this standard and in this episode, he will provide you with an overview of what it is and who should use it. As he also helped a lot of companies, he also provides tips about the implementation of this Standard.

Don’t miss also a webinar he recorded with Rob Packard from Medical Device Academy regarding the new addendums to this standard.

Who is Leo Eisner?

Leo Eisner is the Principal Regulatory and Compliance Consultant of Eisner Safety Consultants. Leo’s been involved in IEC 60601 (Medical Electrical Equipment) for 26 years and involved in the development of the IEC 60601 series (on multiple committees, including the interpretations committee) for about 15 years, the CB Scheme ETF-3 Risk Management Group and recently joined the ISO 15223-1 committee. Leo was on an expert panel for the ASCA program on IEC 60601 through the FDA’s CDRH Standards and Conformity Assessment group in May 2018. He’s audited for several EU Notified Bodies and is currently a technical reviewer on Medical Electrical Equipment & an NB auditor for NSAI. Leo started his career at UL back in 1985 and worked in a variety of non-medical areas from alarms, ATMs, HVAC, microwaves, computers, plastics, etc. for 9 years then found medical devices and never turned back.

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

• Eisner Security Consultant Website: www.EisnerSafety.com
• Leo Eisner LinkedIn Profile: https://www.linkedin.com/in/leoeisnersafetyconsultants/
• Leo Eisner Twitter: https://twitter.com/eisnersafety
• Medical Device Academy Webinar: https://www.youtube.com/watch?v=W8LPfXi2qNk&feature=youtu.be
• Download Slide: https://mailchi.mp/easymedicaldevice/88

The post Best overview of IEC 60601 for Medical Device electrical equipment 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.

IEC 60601 is one of the most important standard to look at if you have an electrical medical devices. In this episode Leonard Eisner also called the IEC 60601 guy will help us understand the full situation. So be ready to learn a lot today. The post Best overview of IEC 60601 for Medical Device electrical equipment appeared first on Medical Device made Easy Podcast.