How I Support the Medical Device Industry

Regulatory Strategy

Determine if a product is a regulated medical device
Classification, product code and regulation determination
Testing requirements
Labeling requirements
Premarket submission type and required inputs
Predicate device research
Documentation review

Device Submissions

Premarket Notifications [510(k)s]
Refuse to Accept' and 'Additional Information' responses
513(g) Requests for Classification
Requests for Designation (RFDs) to OCP
Q-Submission meetings
De novo submissions
Breakthrough Device designation requests
IDE submission support

Other Regulatory Support

Post-market evaluation of device changes for impact on regulatory status / Letter-to-file
Labeling and marketing claims compliance
IFU development
Review and assistance in completing risk assessments
Import/Export issues
General 'ad hoc' regulatory advice