Best overview of IEC 60601 for Medical Device electrical equipment
In this episode of the Medical Device made Easy Podcast, I have invited Leo Eisner from Eisner Security Consultants to help us understand the standards IEC 60601 series.
Leo is an expert for this standard and in this episode, he will provide you with an overview of what it is and who should use it. As he also helped a lot of companies, he also provides tips about the implementation of this Standard.
Don’t miss also a webinar he recorded with Rob Packard from Medical Device Academy regarding the new addendums to this standard.
Who is Leo Eisner?
Leo Eisner is the Principal Regulatory and Compliance Consultant of Eisner Safety Consultants. Leo’s been involved in IEC 60601 (Medical Electrical Equipment) for 26 years and involved in the development of the IEC 60601 series (on multiple committees, including the interpretations committee) for about 15 years, the CB Scheme ETF-3 Risk Management Group and recently joined the ISO 15223-1 committee. Leo was on an expert panel for the ASCA program on IEC 60601 through the FDA’s CDRH Standards and Conformity Assessment group in May 2018. He’s audited for several EU Notified Bodies and is currently a technical reviewer on Medical Electrical Equipment & an NB auditor for NSAI. Leo started his career at UL back in 1985 and worked in a variety of non-medical areas from alarms, ATMs, HVAC, microwaves, computers, plastics, etc. for 9 years then found medical devices and never turned back.
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…
Links
- Eisner Security Consultant Website: www.EisnerSafety.com
- Leo Eisner LinkedIn Profile: https://www.linkedin.com/in/leoeisnersafetyconsultants/
- Leo Eisner Twitter: https://twitter.com/eisnersafety
- Medical Device Academy Webinar: https://www.youtube.com/watch?v=W8LPfXi2qNk&feature=youtu.be
- Download Slide: https://mailchi.mp/easymedicaldevice/88
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