Regulatory
i2r Medical 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 Medical
- 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 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.
i2r Medical News
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NEW Website for 2022
Due to growing demand for our wide range of innovation services, we are undergoing a rebrand which includes a new website. We have listened to
CPI Health Tech Regulatory Support
i2r Medical has been successful in being awarded contracts to support the CPI Health Tech Programme for Regulatory Assistance.
Innovation Toolkit
Over a period of more than 10 years working with innovators, i2r Medical have developed a unique set of innovation tools.