Hellow guys, Welcome to my website, and you are watching Radiation Sterilisation Master File (ISO 11137 & 11607). and this vIdeo is uploaded by Easy Medical Device at 2024-04-09T03:00:21-07:00. We are pramote this video only for entertainment and educational perpose only. So, I hop you like our website.
| Name | Radiation Sterilisation Master File (ISO 11137 & 11607) |
| Video Uploader | Video From Easy Medical Device |
| Upload Date | This Video Uploaded At 09-04-2024 10:00:21 |
| Video Discription | 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 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/ 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 ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance |
| Category | Education |
| Tags | medical devices | medtech industry | medical device regulation | regulatory affairs medical devices | medical device training |
