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Hi Millicent, Since you are long on education and short on experience, I would recommend pursuing alternate positions to bolster your already strong resume. In general, Boston has difficulty finding device personnel. Look for a position where a rotation through different functions is offered, these ...

I am not following what being a consultant has to do with this, but the answer is straightforward, so here goes. Hope it helps. Figure out the Product code and Regulation number. Most Class I are exempt from 510(k) reqs, some are exempt from GMP too. Follow the link to get FDA required info for the ...

Warning: You may not like my answer. I have used many different commercial tools, including Excel. Any of them work, whatever one you choose make sure to validate it for its intended use within your quality system. Don't stop there. Just in case someone reading this assumes the correct tool automatically ...

There is SO much stuff available without taking a course. Consider just the FDA website; * CDRHLearn - https://www.fda.gov/training-and-continuing-education/cdrh-learn * Presentations - https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/applying-human-factors-and-usabi ...

Be clear in your head whether you are branching out to be a contractor or a consultant. Consultants work under a contract, but contractors are not necessarily consultants. Consultants bring deep industry knowledge and best practices to the table, contractors may possess some of the same skillset, but ...