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)
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
