Regulatory Support

Medical Device Quality and Certification

We assist clients with laboratory testing, certifications, compliance and regulatory affairs to the extent required by each project. These may include:

  • FDA requirements (510k notification, etc)
  • GMP/cGMPs (Good Manufacturing Practices)
  • Quality Management Systems (QMS), QSRs
  • CE Mark, ISO Certification (9000, 9001, 9002, 13485…)
  • EMC, EMI, IEC 60601 Compliance
  • CSA/UL registration
  • IEC 60601 and various FDA Cert’s and registration requirements