{"id":4770,"date":"2016-04-01T01:11:14","date_gmt":"2016-04-01T01:11:14","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4770"},"modified":"2022-06-12T18:25:32","modified_gmt":"2022-06-12T18:25:32","slug":"need-help-with-your-medical-device-see-you-in-sf-bay-area-end-apr-san-diego-early-may-16","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2016\/04\/01\/need-help-with-your-medical-device-see-you-in-sf-bay-area-end-apr-san-diego-early-may-16\/","title":{"rendered":"Need Help with Your Medical Device – See You in SF Bay Area End Apr & San Diego Early May ’16"},"content":{"rendered":"

\"\"Are you in the process of designing a medical electrical\u00a0device or\u00a0need some help in meeting\u00a0IEC 60601-1 and related standards? Do\u00a0you need help with a medical device regulatory submission or your quality system? \u00a0Also, we\u00a0have a team of medical device experts<\/a> (some of whom worked at the FDA, \u00a0at EU MDD\u00a0Notified 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. \u00a0We have all your needs covered<\/a>.<\/p>\n

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\"\"If you are in the San Francisco Bay Area you are in luck as I, Leo Eisner<\/a>, can visit you for a complimentary meeting\u00a0on April 27 or\u00a0April 28, 2016. If you are in San Diego Area you will need to come my way as I will be attending the 10X conference<\/a> but would be happy to spend some time meeting with\u00a0you on May 3 or 4, 2016. \u00a0Please contact me, by calling 503-244-61515 or e-mail me at Leo@EisnerSafety.com now to schedule an appointment at your SF Bay Area facility or to meet me\u00a0while I am in the San Diego area.<\/p>\n

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\"\"I have been consulting for over 18 years focused on the 60601 series of medical device standards &\u00a0have a broad regulatory &\u00a0quality systems knowledge from my Notified Body auditor experience. \u00a0I have worked with IEC 60601 series of standards since ’94\u00a0&\u00a0I have been in the product safety industry since ’85. \u00a0I am heavily involved in the development of IEC 60601-1 series of standards &\u00a0Home Use Medical Electrical Standards such as IEC 60601-1-11\u00a0&\u00a0the newer IEC System Committee for\u00a0Active Assisted Living System Committee also known as AAL SyC. \u00a0Some of my standards committee involvement &\u00a0background is below:<\/p>\n