REGULATORY SERVICES FOR MEDICAL DEVICES INDUSTRIES

  • ISO 13485 and FDA compliance evaluations
  • Global regulatory strategies, FDA 513(g) requests and product classifications
  • Technical writing such as 510(k) submissions, explanation letters and clinical reviews
  • EU MDR 2017/745 and IVDR compliance through the following services
    • A comprehensive review of product portfolios and current certificate expiry dates
    • Gap assessment
    • Remediation and implementation of an EU MDR compliance plan
  • Post Approval support
    • Root cause investigation
    • Corrective and preventive action support
    • Complaint handling
    • Recall management
  • Consultation certification for manufacturers
    • USFDA 21 CFR part 820 Quality System Regulations
    • ISO 13485 Certifications
    • ISO 15378 Certifications
    • ISO 9001:2015 Certifications
  • Classification of medical devices
  • Identifying the appropriate pre-market submission pathway
  • Review of pre-clinical & clinical trial data
  • Compilation and Review of PMA, PMN, HDE applications in the specified formats by ensuring compliance with regulations pertaining to respective Health Authorities
  • Submission of application with relevant regulators to register the establishment & list the device
  • Post market regulations & processes : Monitoring & reporting patient incidents, involving the device, both to the manufacturer & to the FDA