How to choose the best Sterilization Method for Medical Devices?
Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization process you should follow for your devices because this will lead to the question of which material you should use to build your device… So to help us have a clear understanding of how Sterilization should be defined for your medical devices, I have invited Jane Scally from Trinzo.
Who is Jane Scally?
Jane has supported medical device manufacturers around the world in the areas of quality management systems, remediation, strategic growth and planning, M&A due diligence and integration management, MDR transition, biocompatibility, and sterilization. Jane has Notified Body experience, performing QMS site audits in tandem with technical documentation reviews. These activities supported manufacturers maintaining their certification under the Directives and those transitioning to MDR 2017/745. Jane holds a Bachelor of Science in Applied Biology and Biopharmaceutical Science, a Higher Diploma in Pharmaceutical Business, and a Master of Science in Medical Technology Regulatory Affairs.
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
- Jane Scally LinkedIn Profile: https://www.linkedin.com/in/jane-scally-b07206a5/
- Trinzo Website: https://www.trinzo.com/
- EU UK Swiss Authorized Representative and Importer: https://easymedicaldevice.com/authorised-representative-and-importer/
- eQMS Scube SmartEye: https://scube-technologies.com/
2 Replies to “How to choose the best Sterilization Method for Medical Devices?”
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Sometimes the medical devices have to offer a sterile outside surface in addition to the mandatory internal path. If the device isused in a strile environment such as during operating environment. Do you advise on teh material selection as pects for these criteria.
Do you also help in the cycle development, and the sterilizer qualifications for dedicated sterilization chanmbers.
What are teh applicable ISO standards for Gamma radiation, ETO, Electron Beam, Vaprozed Hyderogen Peroxide, and Steam steriization methods