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510k Consulting

Premarket Notification 510(k) Consulting and Training Services

510(k)

We are offering a full package of 510(k) consulting services including helping industry establish and maintain a quality management system (QMS or aka cGMP) 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)

510(k) Templates and 510(k) Drafting/Training Seminars.

510(k) Templates for Purchase

510(k) Drafting and Other Training Seminars

Last Updated: 2020-06-06