How to evaluate your Medical Device in 3 Steps (EU MDR 2017|745)

► Webpage:

This week we’ll start back with the basic steps to follow to evaluate your Medical Devices. It will seem basic for some people but you should not be so sure.


The new EU MDR 2017/745 is coming with many surprises and one of them is the fact that some products without a Medical purpose will now be considered as a Medical Device. So what you think is now changing.


With Heikki Pitkänen from Lean Entries, we will explore 3 steps with you to evaluate your Medical Devices. It’S clearly mandatory for you to go through them.

■ Step 1: Qualification of your Medical Device

■ Step 2: Classification of your Medical Device

■ Step 3: Best route to assess your Medical Device

After you followed those 3 steps, you are nearly sure to have a project built on a clear foundation.



In this episode, Heikki offers you access to his platform so you can evaluate your Medical Device and learn more about it. Don’t forget to download the giveaway which includes the promo code.



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► Who is Heikki Pitkänen?

Heikki is the CEO and founder of Lean Entries Ltd., a group of regulatory experts in the area of global medical device regulations providing unique digital regulatory services as well as traditional consulting for the MedTech sector from academies and startups to multinational enterprises.



Heikki has two decades of experience from medical device development, certification, accredited testing and standardization, most lately as the Notified Body site manager at SGS. He is a member of the CEN-CENELEC Advisory Board for Healthcare Standards.



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► 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...

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► Links from the Video
■ Heikki Pitkänen Linkedin:

■ Lean Entries Website:

■ Giveaway with Promo Code:

■ Podcast episode 3: Is my product a Medical Device:

■ Qualify a Medical Device:

■ Classification of a Medical Device:

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► Social Media to follow

■ Monir El Azzouzi Linkedin:
■ Twitter:
■ Pinterest:
■ Instagram:

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#medtech #medicaldevice #compliance

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