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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Innovation Toolkit
Over a period of more than 10 years working with innovators, i2r MedTech have developed a unique set of innovation tools.