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

In this monthly episode of the podcast, we talk about all that happened to the Medical Device industry. This is the July 2020 Update.

Within the Hot Topics, we will talk about the UK MHRA which warns about the “Certificate of Compliance” issued by certain certification bodies. We will also review the publication of the EU Commission regarding the PPE conformity assessment. And I will tell you the situation regarding the State of Play for the EU MDR.

Then we’ll review the Green Belt Certification Program. On the next topic, we will explain to you the situation of Notified Bodies. And some clarification on New Guidance and Standards. Don’t miss the clip regarding the Notified Bodies providing Pre-certification to their customers.

Finally, we’ll review what happened at Easy Medical Device these last weeks. Don’t forget to register for the Green Belt Certification Program.

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…

One Reply to “Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices”

Maura L
August 4, 2020 at 3:40 pm

Thank you for the hot topics, a new story on certification of compliance by an organization, however it is not the regulatory requirement and hence no regulatory validity. So it is clear that the certification is not the same with Declaration of Conformity and then must register their Class I medical device with an EU Competent Authority for medical devices. However it is not clear the issuance bodies which is the certain certification bodies and on what basis they issued the certifications.
It is interesting as well the publication of the EU Commission regarding the PPE conformity assessment, the medical devices which have been used a lot during Covid-19 pandemy and how the quality compliances were controlled.

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

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One Reply to “Medical Device News – July 2020 Update on Quality and Regulatory for Medical Devices”