Regulatory Affairs is constantly evolving and growing. Global harmonization in standards has led to consistent approach in regulatory. Our Regulatory and Compliance team ensures that your products comply with all the regulations and laws pertaining to the industry standards. We keep ourselves up to date with regulatory policies and procedures for one or more countries, as well as maintain an understanding of the scientific and technical background of your products.

  • Regulatory affairs support

    • CE marking support for MDR & IVDR
      • Gap analysis
        • Clause-wise assessment and in-depth Gap analysis of existing documentation
        • Identify if there are gaps requiring remediation in compliance with the regulations and standards.
        • Suggest device classification, applicable Standards, and action items for bringing the documentation into full regulatory compliance
      • Regulatory dossiers
        • Compilation of technical files for medical devices and IVDs and assist the customer with the MDR/IVDR transition process
      • Performance evaluation reports
        • Performance evaluation plan and report compilation as per IVD-Regulation 2017/746 in collaboration with the customer
      • Scientific validity reports
        • Establish the scientific validity claims as per the intended purpose of the IVD device as per IVD-Regulation 2017/746
        • Documentation of the systematic literature procedure, on scientific validity claim
      • Third-party testing
        • Co-ordinate with accredited testing laboratories for Safety, Compliance & Biocompatibility Testing of medical devices
        • Analytical and Clinical Performance testing of IVDs