Medical Device made Easy Podcast
Technology
The EU MDR and IVDR is a bit more demanding on Postmarketing Surveillance. In this episode we will explain to you from the eye of an auditor what they want to see and how you can avoid some mistakes that are always identified.
Who is Steve Curran?Dr Steve Curran has over 20 years experience in the medical device industry both as an engineer and leader developing medical devices but also as a Notified Body regulator ensuring that devices are compliant when they reach the market. He has a broad range of experience from general medical devices to orthopaedic and dental devices and combination devices incorporating drugs and biologics.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
Link:The post How to do Postmarketing Surveillance the right way? appeared first on Medical Device made Easy Podcast. hamza benafqir
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How to accelerate your Laboratory Test Results? [Christoph Lindner]
Medical Device News – January 2022 [Happy New Year]
What happened in 2021? Summary for the Medical Device Industry
The Step-by-Step recipe to get MDR & IVDR Certified
Which devices cannot be Custom-made? [Erik Vollebregt]
Medical Device News: December 2021 Regulatory Update
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How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]
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How to improve your QA RA Communication with Lesley Worthington?
Medical Device News – November 2021 latest update
How does the EU Commission plan to save IVDR 2017/746?
How to comply with MDR when products contain CMR Substances?
EUDAMED Update: Should you register your medical devices now?
Medical Device News – October 2021 Regulatory Update
Why does an Importer/Distributor need to appoint a Notified Body?
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