In today’s market, medical device companies pursuing commercialization need a global regulatory strategy. We offer strategic guidance at every stage of the product development process.

Our regulatory experts have specialized knowledge of the many regulatory jurisdictions, including US FDA (mainly CDRH and CBER), EU/CE, Canada, Australia and beyond. Our support ranges widely, including Notified Body selection, pre-IDE, advisory panel meetings, pre-approval inspections and FDA District Office meetings. We frequently consult in emergency situations to resolve warnings, regulatory actions, and handle product recalls.

How We Work

NAMSA provides regulatory support in multiple ways:

  • Ad hoc hourly consultation and advice
  • Functioning as a virtual regulatory and QA department
  • Providing emergency response teams for Warning Letter resolution, recall handling or audit responses

Common Assignments

  • Regulatory assessment
  • Global regulatory strategy development
  • Pre-IDE meeting preparation, including development of pre-meeting packet
  • Pre-IDE meeting participation
  • Pre-market submissions: 510(k), PMA, BLA, HDE
  • FDA inspection preparation
  • FDA advisory panel preparation and meeting support

Other Needs

Through the years, we’ve supported hundreds of clients seeking regulatory designations, clearances, and international registrations. Our other services include:

  • Agency interaction
  • Device classification and predicate device searches
  • Product modification strategies and management
  • Import and export requirements
  • Labeling and advertising review
  • FDA meetings
  • Real-time reviews
  • International registrations and submissions
  • Device listing and establishment registration
  • Regulatory file letters
  • Creation of technical files
  • Post-market support
  • Recall planning and management
  • Medical device reporting and complaint handling
  • Warning letter resolution
  • Inspection advice and management
  • Quality Systems training — individual or small group, management or production
  • Perform due diligence assessments
  • Audit preparation
  • Acting as Designated Agent for non-US manufacturers
  • Technical papers and abstracts
  • Literature searches and bibliographies
  • Writing and developing SOPs
  • Annual progress reports