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Alan Curtis

Medical Device Consultant

Alan Curtis is a highly experienced professional with over 30 years in the medical device industry, specializing in regulatory strategy for both domestic and international markets.

His expertise lies in regulatory submissions such as IDE, 510k, PMA, Technical Files for CE Mark, as well as clinical trial design, monitoring activities, and submissions to IRBs and Ethic Committees.

Alan has a strong background in implementing Quality Systems in compliance with QSR, Health Canada, ISO 13485:2003, and the Medical Device Directive.

He is well-versed in FDA submissions including IDE, 510k, PMA, PMA Supplements, and PMA Amendments, as well as FDA meetings for Pre-Submission, IDE, submissions, and regulatory discussions.

With a focus on Class I, II, and III devices/systems, Alan has extensive experience in Quality System Implementation, Technical Files for CE Mark, Health Canada's Medical Device License Applications, OUS Regulatory Filings, and Clinical Study Design.

Alan Curtis holds a Bachelor of Applied Science in Microbiology from Cal State East Bay - College Of Business & Economics.

He is currently the Principal at Aec Medical Device Consulting and has held key positions at reputable organizations such as Vice President Regulatory and Clinical and Quality at Viveve, Inc., Aragon Surgical, Associate at W. L. Gore & Associates, Vice President Clinical and Regulatory Affairs and Quality Systems at Surx, Director Quality Systems and Clinical Affairs and Regulatory Affairs at Heraeussurgical/Laserscope, Manager Quality Systems at Aesculap, and Quality Manager at Endosonics Corporation.

Highlights

May 20 · accessdata.fda.gov
[PDF] May 20, 2016 Dr. August Wolff Gmbh & Co. Kg Arzeimittel Ə $ODQ ...
510(k) Premarket Notification - FDA

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Location

Scottsdale, Arizona