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Nancy Singer, JD, FRAPS, RAC

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RE: Managing The Company's Expectations for 510(k) Clearance

Posted By Nancy Singer 22-Apr-2024 15:11
Found In Egroup: Regulatory Open Forum \ view thread
Jonathan - Thanks for providing the link to the recent MDUFA performance report. I am sure many people will find this to be helpful! ------------------------------ Nancy Singer JD, FRAPS, RAC President, Compliance-Alliance Compliance-Alliance Newport Coast CA United States ------------------------ ...

RE: Managing The Company's Expectations for 510(k) Clearance

Posted By Nancy Singer 22-Apr-2024 15:09
Found In Egroup: Regulatory Open Forum \ view thread
Marianne - I really like your suggestion to provide two dates. This will increase your credibility. ------------------------------ Nancy Singer JD, FRAPS, RAC President, Compliance-Alliance Compliance-Alliance Newport Coast CA United States ------------------------------

RE: Managing The Company's Expectations for 510(k) Clearance

Posted By Nancy Singer 19-Apr-2024 15:37
Found In Egroup: Regulatory Open Forum \ view thread
Ed - Thanks for your great suggestion. ------------------------------ Nancy Singer JD, FRAPS, RAC President, Compliance-Alliance Compliance-Alliance Newport Coast CA United States ------------------------------

RE: Managing The Company's Expectations for 510(k) Clearance

Posted By Nancy Singer 19-Apr-2024 15:36
Found In Egroup: Regulatory Open Forum \ view thread
Victor - Your answer clearly shows that you have extensive experience as a regulatory professional. I believe every regulatory professional should follow your advice on how to form a collaborative relationship with the marketing function.. ------------------------------ Nancy Singer JD, FRAPS, RAC ...

RE: Managing The Company's Expectations for 510(k) Clearance

Posted By Nancy Singer 19-Apr-2024 15:26
Found In Egroup: Regulatory Open Forum \ view thread
Sara, Thanks for replying. Your suggestion to include your assumptions is great not only in this instance, but whenever you give projections to senior management or other functions within your organizations. ------------------------------ Nancy Singer JD, FRAPS, RAC President, Compliance-Alliance ...