Medical Device made Easy Podcast

Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

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Episoder(406)

AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]

AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]

If you are working with Artifical Intelligence for your Medical Devices, then this episode is for you. We are alerting you about the new legislation that is planned for all Artificial Intelligence sof...

19 Jul 20220s

Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)

Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)

During my visit to the Medtech Europe Forum I had the chance to meet Fabien, Peter, Ronald, Inna and Rana. They shared with me some great information. Don't miss their interview. The post Medtech Euro...

12 Jul 20220s

Medical Device News – July 2022 Regulatory Update

Medical Device News – July 2022 Regulatory Update

This podcast episode is the monthly review of the regulatory situation. Don't forget to download the document with all the links. The post Medical Device News – July 2022 Regulatory Update appeared fi...

5 Jul 20220s

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

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

This is your last year to be compliant to UKCA otherwise Bye Bye the UK market. We tell you everything with Adam Rae on this episode. So listen carefuly and don't forget to download the cheat sheet. T...

28 Jun 20220s

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

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

We may think that ISO 13485 certification is only for Medical Device manufacturers but in this episode you will hear Cristina Miroescu from Sofmedica Group tell us why its company decided to be certif...

21 Jun 20220s

What are some Quality Common Mistakes? [Karandeep Badwal]

What are some Quality Common Mistakes? [Karandeep Badwal]

Karandeep Badwal will list us some of the common mistakes that he has always noticed. I will confirm some of them. If you are able to solve those you have made already 70% of the problems resolved. En...

14 Jun 20220s

Medical Device News: June 2022 Regulatory Update

Medical Device News: June 2022 Regulatory Update

Medical device news June 2022 is focusing on IVDR 2017/746 date of applciation and consequences. Don't miss all the additional information on guidances, Training,,, The post Medical Device News: June ...

7 Jun 20220s

Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea

Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea

We have worked since more than a year on an eQMS called SmartEye and I have invited Anindya Mookerjea the CEO of SCube Technologies to present the tool and talk about the advantages of electronic Qual...

31 Mai 20220s

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