Medical Devices

Regulatory and Compliance

  • Technical writing and/or review of communications with and submissions to regulatory agencies, including IDEs, PMAs, 510ks and any required reports
  • Internal and external Quality Systems Audits according to US and EU regulatory requirements and/or unique client requirements
  • Remediation Programs (e.g. for actions required from warning letters, partner audits, internal audits, etc.)
  • Mock inspections in preparation for regulatory, certification, accreditation, or notified body inspections