Medical Device Regulatory Compliance Services

Owlpharma provides multidisciplinary expertise to support Medical Device (MD) and In Vitro Diagnostic Device (IVD) manufacturers throughout the entire product lifecycle. Our services are designed to ensure compliance with applicable regulatory and quality requirements, helping companies bring safe, effective, and high-quality products to market and maintain compliance throughout their commercialization.

Our services include:

• Technical Support

  • MD and IVD Classification

  • Technical Documentation

  • General Safety and Performance Requirements (GSPRs)

  • Clinical Evaluation Reports (CER)

  • Gap Analysis

• Regulatory Compliance

  • Quality Management System (QMS) implementation and audits

  • Person Responsible for Regulatory Compliance (PRRC)

  • Risk Management

• Post-Market Surveillance

  • Post-Market Surveillance (PMS) systems

  • PMS plans and reports

  • Post-Market Clinical Follow-up (PMCF)

  • Periodic Safety Update Reports (PSUR)

  • Vigilance activities

  • Supply interruption notifications

• CE Marking & Registration

  • Liaison with Notified Bodies (NB)

  • MD/IVD and Economic Operator Registration