Regulatory Services

 

Regulatory Services that can be integrated into the end to end development process offered by i2r Medical

  • Compilation of a technical file for CE marking of a medical product to the current and future regulations; (Medical Device Directive (MDD), In Vitro Device Directive (IVDD), Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR).
  • Construction of Quality Management System (QMS) compliant to ISO13485: 2016
  • Identification of applicable standards relevant to the design and development of medical products e.g. IEC 60601 (Electrical safety, EMC, Usability, Home healthcare) and Bio-compatibility etc.
  • FDA 510k submission support and guidance
  • Assistance with building and maintaining a Risk Management File to ISO 14971

i2r Medical approaches the regulatory aspects of commercialising a medical product as an integrated part of the development process and ensures that the documentation is minimised but sufficient to achieve compliance.

i2r Medical also works with a large range of specialist medical device suppliers and sub-contractors that are able to transition a prototype medical product into full scale production supported by the necessary Regulatory approvals.