S/AER and MDR ~ FDA Consulting Services
As part of our FDA consulting services, we offer assistance with S/AER (Serious Adverse Event Reporting) and MDR (Medical Device Reporting) for FDA regulated industries.
Our team of FDA consultants includes industry experts and former FDA employees who have expertise in:
S/AER and MDR consulting services include best practices for:
- recordkeeping
- product recalls
- product corrections
- product removals
- compliance with all FDA rules and regulatory actions