510k Consulting

Premarket Notification 510(k)

510(k) Consulting Services

510(k)

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)

We provide 510(k) templates and 510(k) drafting/training seminars.

510(k) Templates

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

510(k) Drafting and Other Training Seminars

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

Last Updated: 2018-12-12