Medical Device made Easy Podcast

Attention! 1 year before UKCA is the law for Medical Devices in the UK

28 Jun 2022

Contributed by Lukas

This episode will alert you about the UKCA deadline for the UK market. So if you are selling products to the UK or if you plan to, you need to listen ...

Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]

21 Jun 2022

Contributed by Lukas

When we think of ISO 13485 certificate we mainly associate it with Medical Device manufacturers. But this can be also associated with other Medical De...

How to avoid these common mistakes on your Quality System? [Karandeep Badwal]

14 Jun 2022

Contributed by Lukas

In this episode, Karandeep Badwal will introduce you to the common mistakes that we can see within your company for Quality and Regulatory affairs.Sof...

Medical Device News - June 2022 Regulatory Update

07 Jun 2022

Contributed by Lukas

 Here is your Medical Device Regulatory update. This will be focused on the IVDR 2017/746 that went live. So let's update you on some key changes. W...

Let's introduce our eQMS Smarteye with Anindya Mookerjea

31 May 2022

Contributed by Lukas

Big news, with my partners we have developed an eQMS called SmartEye!!! and we wanted to share with you why an eQMS is needed. For that, I have invite...

What is the EU Medical Device Situation? with Erik Vollebregt

24 May 2022

Contributed by Lukas

The Medtech Forum occurred this year in Barcelona between May 3-5, 2022 During this conference, we recorded a podcast episode with Erik Vollebregt to ...

What happens after the IVDR Date of Application with Colm O’Rourke

17 May 2022

Contributed by Lukas

The IVDR 2017/746 will become live on May 26th, 2022 and this will be the big day for a lot of IVD companies.To talk about the situation under IVDR, I...

Certify your Software as a Medical Device with Vivek Thakkar

10 May 2022

Contributed by Lukas

Do you have a Software as a Medical Device or maybe you plan to have one? Then listen to this episode with Vivek Thakkar which will provide you some i...

Medical Device News - May 2022 Regulatory Update

03 May 2022

Contributed by Lukas

In this episode, I will update you regarding all the changes in the Medical Device Quality and Regulatory Field. Below are all the topics we will disc...

Training Procedure "How to avoid mistakes" with Rod Beuzeval and Katie Cooney

26 Apr 2022

Contributed by Lukas

The training process can create a lot of non-conformances during audits and this is why we will try to explain to you how to avoid that. Rod and Katie...

How your PMCF is evaluated by your Notified Body? [Matthias Fink]

19 Apr 2022

Contributed by Lukas

PMCF is something that was existing before with MDD 93/42/EC but this is more in focus now with the new EU MDR 2017/745. In this episode, I have invit...

Prepare your audit with a Front Room Back Room

12 Apr 2022

Contributed by Lukas

When you get audited, the configuration Front Room Back Room can help you a lot. But how to prepare for it? How to communicate between them? What are ...

Medical Device News: April 2022 Regulatory Update

05 Apr 2022

Contributed by Lukas

HOT TOPICJoint implementation and preparedness plan for Regulation 2017/746: https://lnkd.in/dasedpRAMDCG 2019-9 Rev 1 – SSCP update https://ec.e...

What are some of the surprises during MDR and IVDR transition? [Erik Vollebregt]

29 Mar 2022

Contributed by Lukas

There was an announcement earlier about the transfer of the Expert Panel for EU MDR & IVDR to the European Medicine Agency. So Pharma will take ca...

How to sell Medical Devices on an Online Platform? [Michael Wetherington]

22 Mar 2022

Contributed by Lukas

Since the implementation of EU MDR, there was a new phenomenon about Medical Device online sales. Online sales see their submissions to platforms like...

Which lessons did we learn doing Clinical Evaluations? [Cesare Magri]

15 Mar 2022

Contributed by Lukas

Since MDR is live we get from surprises to surprises. And we wanted in this episode to share with you some lessons learned regarding Clinical Evaluati...

IVDR Class D Common Specification with Andreas Stange [TÜV SÜD]

08 Mar 2022

Contributed by Lukas

For IVDR products, there is more and more information that is coming.So we make a small summary with Andreas Stange from TÜV SÜD and then we will di...

Medical Device News - March 2022 Regulatory Update

01 Mar 2022

Contributed by Lukas

HOT TOPICSIVDRCommon Specification certain Class D IVD – https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13304-In-vitro-d...

Why do you need a Swiss Authorised Representative and Importer?

22 Feb 2022

Contributed by Lukas

 Since May 26th, 2021 Switzerland is now considered as non-EU country for Medical Devices. So to sell your products in Switzerland you need a Swiss A...

How to have a great Management Review?

15 Feb 2022

Contributed by Lukas

When we talk about Management Review, this is not really obvious how this should be done. In this video, I will try to explain to you what is expected...

Why Design History File (DHF) is so important? [Alexandros Savvidis]

08 Feb 2022

Contributed by Lukas

DHF or Design History File or DMR or DHR or … What does all this mean? We will focus on DHF but we’ll also provide an explanation of the other acr...

Medical Device News - February 2022 Regulatory Update

01 Feb 2022

Contributed by Lukas

The February 2022 Regulatory Update contains a lot of information that may help you to maintain your team up-to-date with the new requirements.Agenda:...

MDCG 2021-27 Placing on the market and Importer Re-labelling with Erik Vollebregt

25 Jan 2022

Contributed by Lukas

The MDCG 2021-27 on Articles 13 and 14 of the EU MDR 2017/745 is creating some problems because of the vocabulary used. Erik Vollebregt, a lawyer at A...

How to interview QA RA candidates with Mitch Robbins

18 Jan 2022

Contributed by Lukas

If you are a Quality or Regulatory affairs hiring manager then you may need to understand how to interview your candidates. I have asked Mitch Robbins...

How to accelerate your Laboratory Test Results? [Christoph Lindner]

11 Jan 2022

Contributed by Lukas

I am sure you were in this situation where you had to execute some Laboratory Tests for the compliance of your medical device and thought that you jus...

Medical Device News – January 2022 [Happy New Year]

04 Jan 2022

Contributed by Lukas

https://www.youtube.com/embed/Q_KBCug4-TQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

What happened in 2021? Summary for the Medical Device Industry

28 Dec 2021

Contributed by Lukas

https://www.youtube.com/embed/ioVmk2qqy3Y?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

The Step-by-Step recipe to get MDR & IVDR Certified

21 Dec 2021

Contributed by Lukas

https://www.youtube.com/embed/UHkw4btTI8A?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Which devices cannot be Custom-made? [Erik Vollebregt]

14 Dec 2021

Contributed by Lukas

https://www.youtube.com/embed/GDuBS1bbhyk?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Medical Device News: December 2021 Regulatory Update

07 Dec 2021

Contributed by Lukas

https://www.youtube.com/embed/g1QbJ7hLG4Q?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Let’s unleash “MDR Classification surprises” [MDR 2017/745]

30 Nov 2021

Contributed by Lukas

https://www.youtube.com/embed/VAY7JvHq9Eg?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]

23 Nov 2021

Contributed by Lukas

https://www.youtube.com/embed/1HBy0f9OU4s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Is it possible to Private Label a Medical Device under MDR & IVDR?

16 Nov 2021

Contributed by Lukas

https://www.youtube.com/embed/CH2WHpLZvtY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to improve your QA RA Communication with Lesley Worthington?

09 Nov 2021

Contributed by Lukas

https://www.youtube.com/embed/8pQBphL1ACQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Medical Device News – November 2021 latest update

02 Nov 2021

Contributed by Lukas

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

How does the EU Commission plan to save IVDR 2017/746?

26 Oct 2021

Contributed by Lukas

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

How to comply with MDR when products contain CMR Substances?

19 Oct 2021

Contributed by Lukas

https://www.youtube.com/embed/a8_1vaWODe8?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

EUDAMED Update: Should you register your medical devices now?

12 Oct 2021

Contributed by Lukas

https://www.youtube.com/embed/B4AbITzsGqI?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Medical Device News – October 2021 Regulatory Update

05 Oct 2021

Contributed by Lukas

https://www.youtube.com/embed/vAavjG5D27M?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Why does an Importer/Distributor need to appoint a Notified Body?

28 Sep 2021

Contributed by Lukas

https://www.youtube.com/embed/qWxBDyOvFS4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]

21 Sep 2021

Contributed by Lukas

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

How to manage the IVDR transition period? [IVDR 2017/745]

14 Sep 2021

Contributed by Lukas

https://www.youtube.com/embed/18tegmDCj3Y?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Is it a good idea to sue my Notified Body? [Erik Vollebregt]

07 Sep 2021

Contributed by Lukas

https://www.youtube.com/embed/Aflq1dNad-U?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Medical Device News – September 2021 Latest Updates

31 Aug 2021

Contributed by Lukas

https://www.youtube.com/embed/1hHE3I9f-lc?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)

24 Aug 2021

Contributed by Lukas

https://www.youtube.com/embed/M6SDznPQI08?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Better to be a Consultant or a Full-time employee? [Lifescience industry]

17 Aug 2021

Contributed by Lukas

https://www.youtube.com/embed/ZrvfoOaSP8s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]

10 Aug 2021

Contributed by Lukas

https://www.youtube.com/embed/B4iA03eOLAw?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Medical Device News – August 2021 Regulatory Update [MDR & IVDR]

03 Aug 2021

Contributed by Lukas

https://www.youtube.com/embed/_AhV5CWgL1s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to implement Vigilance Reporting for MDR and IVDR?

27 Jul 2021

Contributed by Lukas

https://www.youtube.com/embed/4bboTY74eAI?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

System and Procedure Pack the RETURN with Erik Vollebregt

20 Jul 2021

Contributed by Lukas

https://www.youtube.com/embed/goY0i8fmcNY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to interpret the first Expert Panel Opinion? [Bassil Akra]

13 Jul 2021

Contributed by Lukas

https://www.youtube.com/embed/1RsFhuir0TY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]

06 Jul 2021

Contributed by Lukas

https://www.youtube.com/embed/hpn7PDIYD_s?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to build your State-of-the-art for your Medical Devices?

29 Jun 2021

Contributed by Lukas

https://www.youtube.com/embed/TgSIZJ9OxIE?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How Intellectual Property is linked to the Medical Device Regulation?

22 Jun 2021

Contributed by Lukas

https://www.youtube.com/embed/yUXFXfV7lgQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to perform a good Clinical Investigation with Helene Quie

15 Jun 2021

Contributed by Lukas

https://www.youtube.com/embed/LMntcMB5aUc?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to perform a Biological Evaluation for your Medical Device?

08 Jun 2021

Contributed by Lukas

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

Medical Device News – June 2021 Update [EU MDR Date of Application]

01 Jun 2021

Contributed by Lukas

https://www.youtube.com/embed/fq45NSs4Mt4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson]

25 May 2021

Contributed by Lukas

https://www.youtube.com/embed/tZNAV8nTIgQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

MDR is coming so brace yourself with Erik Vollebregt

18 May 2021

Contributed by Lukas

https://www.youtube.com/embed/-b9dPZOZnGs?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

FDA: Is the Emergency Use Authorization worth it? (EUA)

11 May 2021

Contributed by Lukas

https://www.youtube.com/embed/8VrtwglOVu4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Medical Device News – May 2021 Update [EU MDR 2017/745]

04 May 2021

Contributed by Lukas

https://www.youtube.com/embed/_Pbb7ssLks0?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Checklist – What is important before the EU MDR Date of Application?

27 Apr 2021

Contributed by Lukas

https://www.youtube.com/embed/8qSqbqnqZOU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to perform correctly a Merger & Acquisition during the MDR transition?

20 Apr 2021

Contributed by Lukas

https://www.youtube.com/embed/7m1CF5uM-TA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Will it be really difficult for IVD manufacturers? [IVDR 2017/746]

30 Mar 2021

Contributed by Lukas

https://www.youtube.com/embed/aGc9pXaYTeU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to create a Label under MDR? (Questions & Answers)

23 Mar 2021

Contributed by Lukas

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

How System and Procedure Pack are regulated under EU MDR?

16 Mar 2021

Contributed by Lukas

https://www.youtube.com/embed/HoqcVBAr960?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to import your Medical Devices with an Independent Importer?

09 Mar 2021

Contributed by Lukas

https://www.youtube.com/embed/k3gY8mDpGj4?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

What is the Medical Device News? [March 2021 update]

02 Mar 2021

Contributed by Lukas

https://www.youtube.com/embed/PSk7JtreZvg?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

The best design methods for successful development? [Jon Speer]

23 Feb 2021

Contributed by Lukas

https://www.youtube.com/embed/-WqOtzkiM5E?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to find a QA RA job for Medical Devices? [Karandeep Badwal]

16 Feb 2021

Contributed by Lukas

https://www.youtube.com/embed/RV95nolA410?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

What is the QA RA Mindset with Michelle Lott

09 Feb 2021

Contributed by Lukas

https://www.youtube.com/embed/BSsHCkwpt58?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

February 2021 Update – Medical Devices Remote Audit by the EU

02 Feb 2021

Contributed by Lukas

https://www.youtube.com/embed/RXLmLbq9mpA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to perform your PMS more easily with Ivan Perez Chamorro?

26 Jan 2021

Contributed by Lukas

https://www.youtube.com/embed/UVnobMn0yFM?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to get the MDR certification for Artificial Intelligence Softwares?

19 Jan 2021

Contributed by Lukas

https://www.youtube.com/embed/M0XRSo4Ts1U?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to register a Medical Device in Israel? (Liat Nadel)

12 Jan 2021

Contributed by Lukas

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

Medical Device News – January 2021 Update (Monir El Azzouzi)

05 Jan 2021

Contributed by Lukas

https://www.youtube.com/embed/Orw5xqcOimU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How Easy Medical Device can help you? (Monir El Azzouzi)

28 Dec 2020

Contributed by Lukas

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

How to deal with Significant Changes within MDR & IVDR with Martin Witte

21 Dec 2020

Contributed by Lukas

https://www.youtube.com/embed/5-aFIL6HI0g?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to register a Medical Device in Mexico? [Josué Garza]

14 Dec 2020

Contributed by Lukas

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

Medical Device News: What happened in November 2020?

07 Dec 2020

Contributed by Lukas

https://www.youtube.com/embed/nB8PMi3LXNE?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Is it Easy for a Notified Body to get EU MDR accredited?

30 Nov 2020

Contributed by Lukas

https://www.youtube.com/embed/DLym6Px7OyU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How a Quality & Regulatory training can help you? [Sofmedica]

23 Nov 2020

Contributed by Lukas

https://www.youtube.com/embed/jVzDa0MBsdA?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Do you need an Expert Panel for your Medical Devices? [Bassil Akra]

16 Nov 2020

Contributed by Lukas

https://www.youtube.com/embed/4NS7WjmetgM?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

What are Common Specifications under EU MDR & IVDR?

09 Nov 2020

Contributed by Lukas

https://www.youtube.com/embed/_5bdNbG1MyY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

We’ve reached episode 100 – What happened for the last 2 years?

02 Nov 2020

Contributed by Lukas

https://www.youtube.com/embed/kuTOkLY4CNY?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to certify a self-testing device under IVDR? [Erik Vollebregt]

26 Oct 2020

Contributed by Lukas

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

What is the cost of EU MDR 2017/745? [Catherine Higginson]

19 Oct 2020

Contributed by Lukas

https://www.youtube.com/embed/A6rkJAO8Vkw?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

How to register your Medical Device in the ASEAN region?

12 Oct 2020

Contributed by Lukas

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

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

05 Oct 2020

Contributed by Lukas

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

How to register ATMP-Device combination products?

28 Sep 2020

Contributed by Lukas

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

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

21 Sep 2020

Contributed by Lukas

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

How can GDPR impact Medical Devices with Erik Vollebregt

14 Sep 2020

Contributed by Lukas

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=...

Be successful at your MDR and IVDR audit with Martin Witte

07 Sep 2020

Contributed by Lukas

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=...

Medical Device News – August 2020 Review (Monir El Azzouzi)

31 Aug 2020

Contributed by Lukas

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

How to switch quickly to a Virtual Conference with TOPRA

24 Aug 2020

Contributed by Lukas

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

Best practice for Device Testing with Michael Wetherington

17 Aug 2020

Contributed by Lukas

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

Best overview of IEC 60601 for Medical Device electrical equipment

10 Aug 2020

Contributed by Lukas

https://www.youtube.com/embed/V1n1FhYfzRU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices

03 Aug 2020

Contributed by Lukas

https://www.youtube.com/embed/6DaMJhtptZQ?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Learn UDI code for Medical Devices with Sylvia Reingardt

27 Jul 2020

Contributed by Lukas

https://www.youtube.com/embed/7jErVlfmS4I?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...

Understand IEC 62304 for Medical Device Software with Adnan Ashfaq

20 Jul 2020

Contributed by Lukas

https://www.youtube.com/embed/8UtCRFYe5XU?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=...