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

- CAPA

-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

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