ARCexperts helps companies that live in regulatory environments understand that compliance is a tool that can give them a competitive advantage. ARCexperts’ compliance strategies cover the entire range of processes from product design to shipping and storage. Our experts ensure life science companies meet FDA approval to manufacture and sell their products globally.

Device Registration and Approval

ARCexperts assist with obtaining medical device registration and approval for many global companies. Our experts have the experience and industry insight to complete your registration in order to obtain medical device approvals competently and professionally.​

​Our experts specialize in providing guidance to meet the following regulations and standards that have been created to help reduce risk:

  • FDA 21 CFR
  • ISO Standards
  • 510(k)
  • CE Mark
  • EU Annex 11
  • Canadian Standards
  • Quality Management Systems
  • Performance Improvement
  • Pre-post M&A Integration
  • Operational Management Structuring
  • Organizational Change Management
  • Information Technology 
  • Validation (IQ, OQ, PQ)
  • IP MAnagement
  • CLIA
  • TS 16949