What does a strategy for regulatory compliance looks like?

Medical Device made Easy Podcast

In this episode, Adam Isaacs Rae will help us shape your Regulatory Compliance Strategy. This is a requirement of the EU MDR and IVDR but it doesn’t provide much information. So, let’s review that together.

Who is Adam Isaacs Rar?

Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.

Who is Monir El Azzouzi?

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.

Links from the Video

• ■ Adam Isaacs Rae linkedin Profile: https://www.linkedin.com/in/adam-isaacs-rae/
• ■ Radiation Sterilisation Master File Template: https://school.easymedicaldevice.com/product/radiation-sterilisation-master-file-template/
• ■ ISO 11137- Radiation standards : https://www.iso.org/standard/33952.html
• ■ ISO 11607 – Packaging of terminally sterilised products: https://www.iso.org/standard/70799.html
• ■ ISO 11737 – Bioburden: https://www.iso.org/standard/66451.html

Social Media to follow

• ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
• ■ Twitter: https://twitter.com/elazzouzim
• ■ Pinterest: https://www.pinterest.com/easymedicaldevice
• ■ Instagram: https://www.instagram.com/easymedicaldevice

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