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Regulatory

Regulatory

i2r MedTech work with you to turn your ideas into workable solutions

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

  • Compilation of a technical file for UKCA and CE marking of a medical product to the current and future regulations; (UKCA, Medical Device Regulations (MDR), In Vitro 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
  • Assistance with finding an EU Representative

i2r MedTech 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 MedTech 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.

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