Medical Device made Easy Podcast podcast

Medical Device made Easy Podcast

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.

 

#238

Transition to Agile for Software as Medical Device

We start to talk more and more of Software as Medical Device or SaMD. This time we will ch... more

25 Apr 2023

36 MINS

36:00

25 Apr 2023


#237

Prepare your audit like a PRO

If you are selling a Medical Device that is not a class I, then you know that you have to ... more

18 Apr 2023

40 MINS

40:55

18 Apr 2023


#236

What is a SOUP for your Software Development

in this context SOUP is not a dish but Software Of Unknown Provenance which is the term us... more

11 Apr 2023

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11 Apr 2023


#235

Medical Device news for April 2023

► Podcast page: [https://podcast.easymedicaldevice.com/226-2/] (https://podcast.easymedica... more

04 Apr 2023

27 MINS

27:38

04 Apr 2023


#234

How to perform Risk Management for a Software ?

In this episode, Bijan Elahi will help us perform risk management for SaMD and give us som... more

28 Mar 2023

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28 Mar 2023


#233

Proactive Postmarketing Surveillance. What does it mean?

The EU MDR is requiring more transparency and for the PMS has a lot to play on it. In this... more

21 Mar 2023

44 MINS

44:36

21 Mar 2023


#232

What you should know about Vigilance Reporting?

Vigilance Reporting is a process that you should have but that you don’t want to us. In fa... more

14 Mar 2023

37 MINS

37:45

14 Mar 2023


#231

Medical Device News: March 2023 Regulatory Update

Here is your Regulatory Update for the month of March 2023. Check all the links below - EU... more

08 Mar 2023

40 MINS

40:20

08 Mar 2023


#230

Principal at Test labs

The EU MDR is planning to be really challenging for Class I reusable Surgical Instruments ... more

28 Feb 2023

32 MINS

32:04

28 Feb 2023


#229

SaMD international reach – What to consider?

We are in a global world, so normally what is good for the EU can be also good for other c... more

21 Feb 2023

35 MINS

35:07

21 Feb 2023


#228

Biological Evaluation: Top Big mistakes

In this podcast episode, Laura and Paul will share with us the big mistakes done by some M... more

14 Feb 2023

54 MINS

54:05

14 Feb 2023


#227

Medical Device News - February 2023 Regulatory Update

Here is your Regulatory Update for the month of February 2023. Check all the links below –... more

07 Feb 2023

25 MINS

25:49

07 Feb 2023


#226

How to do Post-Marketing Surveillance in the US (vs EU)?

We talk a lot about Post Marketing Surveillance in Europe with EU MDR, MDCG, and all the r... more

31 Jan 2023

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31 Jan 2023


#225

How to evaluate Benefit-Risk Ratio for Medical Devices?

The evaluation of the Risk-Benefit ratio is key for Risk Management Files per ISO 14971 or... more

24 Jan 2023

43 MINS

43:59

24 Jan 2023


#224

Breaking News: EU MDR Extension Proposal is out for consultation

Finally, a proposal is now available, and we wanted to discuss it and identify if there ar... more

17 Jan 2023

39 MINS

39:20

17 Jan 2023


#223

How to improve the relationship between QA – RA and Marketing?

In the Medical Device world, you need to work as a team. Sometimes it is really difficult ... more

10 Jan 2023

42 MINS

42:18

10 Jan 2023


#222

Medical Device News: January 2023 Regulatory Update

EU MDR extension ---Implementation of the Medical Device Regulation [https://data.consiliu... more

03 Jan 2023

29 MINS

29:28

03 Jan 2023


#221

Grow your LinkedIn Profile with Karandeep Badwal

Getting some visibility is the key to growing your LinkedIn Profile. And on this episode, ... more

27 Dec 2022

45 MINS

45:19

27 Dec 2022