Every manufacturer of medical devices is required to compile and to keep up to date a technical documentation set, describing the product, its risk characteristics and its manufacturing process. Unitron Regulatory can help you with building up your technical documentation and meeting the legislative obligations to be able to bring your medical device to the market.
For non-medical complex electronic equipment (e.g. active laboratory equipment) a sound technical file complying with the Directives it falls in scope of is just as important as for medical devices. Risk management, safety characteristics, and proper documentation would allow you to quickly and reliably pass the accredited test laboratory demands and tests and to secure your access to the market.
If you believe your technical documentation to be nearly finished already, we can conduct an assessment of your documentation for certification and design transfer necessities, to minimize risk of non-compliance or refusal to accept.
We create high-end life science devices. From design to end product, and from certification to serial production. We have been doing this for global players in the medical sector for more than 30 years. Together, we’re taking healthcare to the next level.Contact us