FDA Compliance Group LLC

Your solution to FDA compliance needs

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
For more information about S/AER and MDR, or to schedule a consultation, please contact us.