FDA 510(k) Medical Device Expert (4154893)

Writing & Translation

FDA 510(k) Medical Device Expert

$150/hr Starting at $100

I am a Regulatory and Medical Writing expert that can help you navigate the requirements for your Class I, II, or III medical device submission, including registration for Class I devices, 510(k), and PMA support. I can act as the US Agent for importers, and offer direct liaison with the agency. As a previous Fortune 50 regulatory affairs Director, I have managed over 50 FDA submissions, as well as EMA and ASIA-PAC regulatory filings. I know how to develop a strategy that gets you to market quickly and with minimal costs. I also support drugs and biologics. If you are just getting started, contact me for a quote on my initial consultation and "roadmap" service. I can support all of your regulatory needs, no matter which stage you are at in development. Thanks, Angela Johnson, MSE, PMP, RAC

About

$150/hr Ongoing

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I am a Regulatory and Medical Writing expert that can help you navigate the requirements for your Class I, II, or III medical device submission, including registration for Class I devices, 510(k), and PMA support. I can act as the US Agent for importers, and offer direct liaison with the agency. As a previous Fortune 50 regulatory affairs Director, I have managed over 50 FDA submissions, as well as EMA and ASIA-PAC regulatory filings. I know how to develop a strategy that gets you to market quickly and with minimal costs. I also support drugs and biologics. If you are just getting started, contact me for a quote on my initial consultation and "roadmap" service. I can support all of your regulatory needs, no matter which stage you are at in development. Thanks, Angela Johnson, MSE, PMP, RAC

Skills & Expertise

Biomedical Device DesignMedical Device DesignMedical WritingRegulatoryRegulatory AffairsWriting

Angela Johnson 5