Eisner Safety Consultants

Eisner Safety Consultants ensure our client’s medical device/IVD compliance needs are met with uncompromising attention to detail and quality. We provide our clients with practical assessments of their products and provide strategies & support to help them through the medical device/IVD product compliance maze. The Eisner Safety Consultants team provides expertise to SMEs and Fortune 500 companies for successful medical device compliance projects on: • design for compliance to IEC 60601 series of standards; • design reviews against applicable requirements; • identification of applicable standards, laws, regulations, directives and guidances; • labeling reviews; • support with test labs • training • regulatory submissions & remediation • and more If you don't see the area you are looking for please ask - we're happy to point you in the right direction if we can't do it ourselves. Leo’s leadership and commitment in the standards development process runs deep and over many years including IEC 60601-1, 4th edition current development work & IEC 60601-1, edition 3.2, US co-chair of AAMI TAG 62D on electromedical equipment, US chair of AAMI EV-WG13 & IEC convener of IEC TC62 / SC 62D / JWG9 on Lens removal and vitrectomy equipment. Leo has been involved in numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years. To see a more detailed list go to Leo’s LinkedIn Profile @ linkedin.com/in/leoeisnersafetyconsultants