Regulatory Guidance and System Support

Keeping you compliant with the dynamic global regulatory environment from a business and technology perspective.

Regulatory Guidance and System Support

Keeping you compliant with the dynamic global regulatory environment from a business and technology perspective.

Ultragenic’s team of business experts keep themselves updated with the latest in global regulatory landscape. They work closely with our technology and safety system teams to develop business and technical guidance & solutions. This ensures complete and timely compliance of PV departments.

Our current Regulatory Guidance and System Support includes:
  • EU MDR MIR Form (Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD))

Ultragenic offers:

  • Creation of additional data entry fields and the definition of conventions
  • Generation and submission of new MIR (v.7.2) Form
  • Compatibility with IMDRF AER codes
  • Notification of Economic Operators (EOs)
  • Periodic Reporting
  • FDA PMSR compliance deadlines. The FDA has set two new PMSR enforcement dates, tied to the system combination product applicants use to submit individual case safety reports, or ICSRs

Ultragenic offers:

  • Interpretation of the regulation vis a vis your safety system configuration
  • Custom profile solution for the Post Marketing Safety Reporting (PMSR) of combination products
  • Rapid 3-4 week deployment with minimal business disruption