Best practice for Device Testing with Michael Wetherington
When you are trying to develop a Medical Device, there is a stage that you cannot avoid which is testing your products. For that, I have invited Michael Wetherington from MedicalRegs.com who will help us understand how to prepare for it. We will also help you understand the way you need to follow to choose your Laboratory.
Tests should be done in a lab but also internally. You should test as much as possible to see if you are in the right direction. We will talk a lot about IEC 60601 as an example but other tests can be mentioned.
Michael will also provide information regarding accredited laboratories. This is not really a guarantee of quality and you should be monitoring them. The labs are providing you with a service so don’t just rely on them to perform the right tests as you know the products better than them.
Who is Michael Wetherington?
Michael Wetherington is the Founder of MedicalRegs.com. MedicalRegs.com helps MedTech startups design devices with the applicable requirements in mind. They go further by providing regulatory services for the EU, US, Canada, and ASEAN markets. His background encompasses medical device R&D, accredited testing lab, and Notified Body experience. He is also a mentor at Elemed’s Mentoring Academy. And, when time permits, he likes to sing, play the drums, and the guitar.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
- Medical Regs Website: https://medicalregs.com
- Michael Wetherington LinkedIn: https://www.linkedin.com/in/medicalregsdotcom/
- US Accreditation website: https://www.osha.gov/dts/otpca/nrtl/nrtllist.html
- How to find your certification body? https://easymedicaldevice.com/accreditation-certification-body/
- Episode 88 – IEC 60601 with Leo Eisner: https://podcast.easymedicaldevice.com/88