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Good day Masami, Having taken the RAC US and EU (and now updating the certification to the Medical Devices cert) many years ago for me was advantageous.  There was 2 or 3 jobs had interviewed over the years where the hiring manager (usually the CEO/President) did not look at any resumes which did not have RAC designation.  After I was hired, they told ...

Dear all, I know it was already asked before but I did not find satisfying answers. Can anybody provide a procedure or at least a flow chart for Medical Device Adverse Event Reporting in Australia? Thanks in advance! Best regards Christian ------------------------------ Christian Rosenzweig Consultant Marburg Germany --------------------------- ...

Dear Anon, As per replies from other forum members and eager as it may be for MDR, we have considered quarterly checking of standards where they publish them in OJEU as best practice: i.e. https://ec.europa.eu/growth/content/new-2020-lists-harmonised-standards-medical-devices-are-now-available_en ------------------------------ Eric Ngo Snr Regulatory ...

35 U.S.C. 271 Infringement of patent. (a) Except as otherwise provided in this title, whoever without authority makes, uses , offers to sell, or sells any patented invention, within the United States, or imports into the United States any patented invention during the term of the patent therefor, infringes the patent. (b) Whoever actively induces infringement ...

Dallas, That is a relic from before the 21 st Century Cures Act was integrated into FDA regulation within the last year. If it meets the definition, currently updated and accurate in the FDA guidance documents that deal with this, it is not regulated at all. See Medical Device Data Systems, Medical Image Storage Devices, and Medical ...