148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. Leo highlights the challenges and strategies for documenting standards assessments and emphasizes the importance of leveraging existing standards to avoid unnecessary development. The episode also covers tips for small and large companies, the significance of early research, and the essential stakeholders involved in standards assessment.

Chapters:

00:00 Introduction to the Combinate Podcast

01:03 Guest Introduction: Leo Eisner

01:19 Understanding Standards Applicability

07:45 Documenting Standards Assessments

12:03 Challenges and Best Practices

20:56 Final Thoughts and Contact Information

Leo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance & regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies & support to help them through the medical device product compliance maze based on his experience.

He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.

Links:

Website: https://eisnersafety.com/

Blog: https://eisnersafety.com/industry_news/ & Sign-up for newsletter on right side of

page (1/2 way down)

LinkedIn: linkedin.com/in/leoeisnersafetyconsultants

Schedule a call: https://eisnersafety.com/schedule-call/