I am the founder and principal compliance and regulatory consultant of Eisner Safety Consultants, we provide the medical device industry with product safety compliance & regulatory support.
I ensure my clients’ medical device compliance needs are met with uncompromising attention to detail and quality. I provide my clients with practical assessments of their product(s) and provide strategies & support to help them through the medical device product compliance maze.
As an expert in the standards development process, I have 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
1. Provided expertise to 100’s of SMEs and Fortune 500 companies for successful medical device compliance projects
2. Reviewed/generated 30+ product safety and labeling/marking sections of EU technical file/technical documentation (MDD/MDR) / DHF for active medical devices and active medical implantables
3. Expert Member of development teams on IEC 60601-1, edition 3.2 (via IEC TC62/SC 62A/MT28 & MT30 & WG14 & IEC TC62A/Ad Hoc Group 62368-60601) and 4th edition of IEC 60601-1 – Working Groups assignments in process currently – https://bit.ly/IEC60601-1FourthEdTimeToGetInvolvedIsNOW
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