510k Information

Premarket Notification 510(k)

510(k) Consulting Services


510K Consulting Services

We are offering a full package of 51ok consulting services including helping industry establish and maintain a quality management system under ISO 13485 or 21 CFR Part 820. 

Our 510(k) services include, but are not limited to, the following.

  • Understand your device
  • Intended use/indications for use
  • Device classification
  • Identify a suitable predicate(s)
  • Determine a traditional 510(k), abbreviated or special 510(k)
  • Tests and testing requirements
  • FDA guidance and special controls: please note FDA finalized the 510(k) guidance, issued dated July 28, 2014
  • Special considerations
  • De Novo process
  • Premarket notification (510k) drafting
  • 510(k) submissions
  • 510(k) clearance
  • Postmarket requirements
  • Establish and maintain quality management systems (QMS)

LIVE 510k Webinar

LIVE | FDA 510(k) Requirements, Submission, and Clearance | Bi-Monthly, 2nd Thursdays | 11: 30 AM PST | 02:30 PM EST | 60 Minutes | Register Here

FDA 510(k) Templates-Ready for Use

FDA 510(k) Templates Ready for Use Compliant with eCopy and RTA Policy | 510K Templates

LIVE Online Seminar Series

LIVE | Good Clinical Practice (GCP) | Register Here
LIVE | US FDA 510(k) Drafting | Register Here
LIVE | US FDA Premarket Approval (PMA) Drafting | Register Here
LIVE | Fundamentals of Regulatory Affairs for Drugs and Medical Devices | Register Here

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Last Updated: 2015-07-24