Premarket Notification 510(k) Consulting and Training Services
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
- Contact Regulatory Doctor by phone, email, or text.
510(k) Drafting and Other Training Seminars
- By invitation only
- Contact Regulatory Doctor here >>
Last Updated: 2020-06-06