FDA 510(k)

Posts tagged with “FDA 510(k)”

Vesna Janic

Advice from a former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations

StarFish Medical recently worked with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations, as part of our ongoing efforts to improve and train our quality practices. During our breaks, I spoke with Larry about life after the FDA, how firms can best prepare for regulatory submissions, and the new open nature of the […]

Vincent Crabtree

5 Tips for FDA 510(k) Medical Device Regulatory Clearance

Some companies experience problems getting FDA Regulatory Clearance using the 510(k) Pre-market Notification process.  As a Product Development company, StarFish Medical’s focus is more on regulatory compliance than strategy.  We believe it is important to consider Regulatory all the way through the development process, and not try to ‘bolt on’ compliance at the end. Here […]

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