Are you in the process of designing a medical electrical device or need some help in meeting IEC 60601-1 and related standards? Do you need help with a medical device regulatory submission or your quality system? Also, we have a team of medical device experts (some of whom worked at the FDA, at EU MDD Notified Bodies, at some of the top test houses, and have great medical device industry experience) in regulatory, risk management, software, EMC, and quality system areas of expertise. We can do your 510(k), EU Technical File, help with your Validation work, write your SOPs, write test plans, write a Clinical Evaluation Report, and much more. We have all your needs covered.
If you are in the San Francisco Bay Area you are in luck as I, Leo Eisner, can visit you for a complimentary meeting on April 27 or April 28, 2016. If you are in San Diego Area you will need to come my way as I will be attending the 10X conference but would be happy to spend some time meeting with you on May 3 or 4, 2016. Please contact me, by calling 503-244-61515 or e-mail me at now to schedule an appointment at your SF Bay Area facility or to meet me while I am in the San Diego area.
I have been consulting for over 18 years focused on the 60601 series of medical device standards & have a broad regulatory & quality systems knowledge from my Notified Body auditor experience. I have worked with IEC 60601 series of standards since ’94 & I have been in the product safety industry since ’85. I am heavily involved in the development of IEC 60601-1 series of standards & Home Use Medical Electrical Standards such as IEC 60601-1-11 & the newer IEC System Committee for Active Assisted Living System Committee also known as AAL SyC. Some of my standards committee involvement & background is below:
- Co-chair of the U.S. TAG (technical advisory group) for IEC/SC 62D,
- Member of the US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) & SC 62D (Electromedical equipment),
- Convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”,
- Member of TC 62/SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1 to testing of medical electrical equipment, and to deal with general testing requirements not assigned to other maintenance teams.)
- Member of AAMI committee for Home Use Medical Devices & US TAG for Active Assisted Living SyC (System Committee for all devices in various categories for the elderly which includes the home use medical device industry).
- Co-author of multiple articles on IEC 60601-1 as can be seen on the Featured Articles web page & is on the Editorial Advisory Board for MD&DI and just became a Senior Contributor to InCompliance Magazine .
- Leo has audited for several EU Notified Bodies and has been a technical reviewer for Medical Electrical Equipment.
- Leo is the manager of a LinkedIn Group – IEC 60601 Series – Medical Electrical Equipment
Please feel free to contact me to arrange a time to meet either at SF Bay Area, California on April 27 or 28th or in San Diego, California on May 3 or 4, 2016, by calling 503-244-61515 or e-mail me at .