Radiation Sterilisation Master File (ISO 11137 & 11607) 

Miniature podcast episode 279 Radiation Sterilisation Master File (ISO 11137 & 11607) Monir El Azzouzi Adam Isaacs Rae easy medical device

If your products need to be sterilized, then you will need to prove that the sterilization process is validated and continues to work all through the life to the product. So Adam Isaacs Rae will provide you with the information on Radiation Sterilization requirements. Standards, guidelines, pitfalls. All this will help you remain compliant. 

Who is Adam Isaacs Rae? 

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 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. 

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episode 279 Radiation Sterilisation Master File (ISO 11137 & 11607) Monir El Azzouzi Adam Isaacs Rae easy medical device

2 Replies to “Radiation Sterilisation Master File (ISO 11137 & 11607) ”

  1. Annette Callaghan

    The information provided on dose audits is misleading. This is an actual low dose study, similar to the dose setting process, not just a review of documentation, calibration and irradiation certificates.

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