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
How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]
How to manage the IVDR transition period? [IVDR 2017/745]
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
Medical Device News – September 2021 Latest Updates
How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)
Better to be a Consultant or a Full-time employee? [Lifescience industry]
What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]
Medical Device News – August 2021 Regulatory Update [MDR & IVDR]
How to implement Vigilance Reporting for MDR and IVDR?
System and Procedure Pack the RETURN with Erik Vollebregt
How to interpret the first Expert Panel Opinion? [Bassil Akra]
Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]
How to build your State-of-the-art for your Medical Devices?
How Intellectual Property is linked to the Medical Device Regulation?
How to perform a good Clinical Investigation with Helene Quie
How to perform a Biological Evaluation for your Medical Device?
Medical Device News – June 2021 Update [EU MDR Date of Application]
EU MDR Survey: What is the Industry’s opinion? [Catherine Higginson]
MDR is coming so brace yourself with Erik Vollebregt
FDA: Is the Emergency Use Authorization worth it? (EUA)
Create your
podcast in
minutes
It is Free
Insight Story: Tech Trends Unpacked
Zero-Shot
Fast Forward by Tomorrow Unlocked: Tech past, tech future
The Unbelivable Truth - Series 1 - 26 including specials and pilot
Lex Fridman Podcast