We provide a range of software regulatory services including but not limited to:

  • Regulatory Strategy & Support
  • Platform Strategy
  • FDA/EU Readiness Evaluation
  • QMS/DHF Implementation
  • Post market support
  • Remediation
  • Software Development

Standards include:

ISO 13485

ISO 14971

IEC 62304

IEC 62366

TIR 45


Specialities:

  • Cybersecuity
  • AI
  • Software