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Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments
On April 3, 2023 FDA added IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment – Part 1: General requirements for basic safety and essential performance to their list of Recognized Consensus Standards as Recognition # 19-49 in Recognition List
IEC 60601-1 Amendment 2 (IEC 60601-1:2005 +A1:2012 + A2:2020) has been in the making since 2015 (officially) along with the other published Amendments (IEC 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, & 60601-1-12). It was published on 20 August 2020 on the
Leo Eisner, the “IEC 60601 Guy”, will be presenting a session at MD&M West on Wednesday, Feb. 6, 2019 from 3:15 – 5:30PM Topic: Why Your Regulatory Strategy Can’t Ignore Medical Electrical Standards & Guidances Track: MD&M West: Regulatory & Quality
Jon Speer, founder and VP of QA/RA @ greenlight.guru (moderator of the webinar) and I, Leo the “IEC 60601-1 guy” Eisner, Principal Consultant of Eisner Safety Consultants, will be presenting a webinar “What You Need to Know About Medical Electrical Equipment