Sheila J. Ramerman

Founder, SJR Associates
Sheila Ramerman, RAC, is the founder and Principal at SJR Associates, a medical device regulatory affairs/quality systems consulting firm with particular emphasis on near-patient testing technologies and in assisting start-up stage companies implement their regulatory, quality, and clinical studies functions. Prior to founding SJR Associates, Ms. Ramerman was responsible for regulatory affairs, quality systems, and/or clinical studies at several medical device companies in the San Francisco Bay Area. She has hands on experience with several kinds of devices (neurology, clinical laboratory, rehabilitative medicine, orthopedic and arthroscopic surgical devices) and with a range of medical device companies, from start-ups to multi-national corporations. She has successfully submitted over 30 510(k) submissions, and recently was instrumental in achieving PMA approval for a novel radiology software product.

She began her career as a Medical Laboratory Technician and Clinical Laboratory Scientist in community hospital laboratories. Ms. Ramerman received an AA in Laboratory Technology from Shoreline Community College in Seattle, WA and a BA in Health Services Administration from Saint Mary’s College in Moraga, CA. She has been Regulatory Affairs Certified (RAC) since 1998.

FDA 510(k) Submissions – Contents, Process, Pitfalls
Live Corporate Webcast
Friday –8thJune – 2012 – 2:00 PM EDT | 11:00 AM PDT

Duration of webcast : 1 hour | Duration of Q/A session : 10-15 mins
Post Session : Copy of Presentation Slides will be shared


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Short Abstract:

FDA requires a 510(k) premarket notification submission for most Class II medical devices, some Class I devices, and even for a few Class III devices – it’s by far the most common type of medical device premarket submission. This webcast presents an overview of 510(k) submissions – when to submit, what kind of 510(k) to use and when, contents of each 510(k) type, the 510(k) review process, and pitfalls to avoid with your submission.

The presentation will cover the following areas:

  • History of 510(k) regulations.
  • When to file a 510(k).
  • Who must file a 510(k).
  • Predicate devices and substantial equivalence.
  • Types of 510(k) submissions.
  • Contents of a 510(k).
  • 510(k) Review process.
  • Pitfalls and common mistakes
  • Resources for more information


Best Regards.