Designing products for regulatory compliance can eliminate surprises! How do you move through this maze? Today I had a great conference call with my old friend of many years, Bill Salzstein. Once we got caught up, we shared ironically same stories about how medical device companies tend to look at the 510(k) process. I can attest to this of what I went through this year,it is how you look at the whole risk mitigation piece in light of the reviewer that can have the ultimate impact on the timeliness of the approval process. Here is the excerpt article that Bill sent to me that is a good read.
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Medical Design for Regulatory Compliance
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