FDA Submissions, CE Marks and Regulatory Affairs

FDA Submissions

510k, 513g, PMA and all Regulatory Compliance 

- International submissions and compliance, CE, EU, Health Canada, Australia, China


-Create and Review Product Change "Letters to File"

-FDA Facility Registration and Device Listing 

-FDA Good Manufacturing Practices (GMP), Quality System 

-FDA Quality System Audit Inspection Support 

-Medical Device Directive Compliance and Support 

-Medical Device Reporting and Complaint System Compliance 

-Quality and Regulatory Affairs Management

- ISO 13485-2016 Certification