Medical Device made Easy Podcast
Technology
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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The post Radiation Sterilisation Master File (ISO 11137 & 11607) appeared first on Medical Device made Easy Podcast. hamza benafqir
Medical Device News – May 2021 Update [EU MDR 2017/745]
Checklist – What is important before the EU MDR Date of Application?
How to perform correctly a Merger & Acquisition during the MDR transition?
Will it be really difficult for IVD manufacturers? [IVDR 2017/746]
How to create a Label under MDR? (Questions & Answers)
How System and Procedure Pack are regulated under EU MDR?
How to import your Medical Devices with an Independent Importer?
What is the Medical Device News? [March 2021 update]
The best design methods for successful development? [Jon Speer]
How to find a QA RA job for Medical Devices? [Karandeep Badwal]
What is the QA RA Mindset with Michelle Lott
February 2021 Update – Medical Devices Remote Audit by the EU
How to perform your PMS more easily with Ivan Perez Chamorro?
How to get the MDR certification for Artificial Intelligence Softwares?
How to register a Medical Device in Israel? (Liat Nadel)
Medical Device News – January 2021 Update (Monir El Azzouzi)
How Easy Medical Device can help you? (Monir El Azzouzi)
How to deal with Significant Changes within MDR & IVDR with Martin Witte
How to register a Medical Device in Mexico? [Josué Garza]
Medical Device News: What happened in November 2020?
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