For non-medical devices (e.g. laboratory equipment), we give advice on the directives and regulations that are applicable to your product. We can conduct a search for consensus standards that allow you the benefit of presumption of conformity with the directive’s requirements. Based on our experience from marketed active devices, we offer advice on the least burdensome approach in building up your technical documentation, to comply with the applicable directives and pass regulator’s controls if they take place. We provide recommendations on the documents to take to the accredited test laboratory for testing required for certification, and on smart ways to reach markets outside European Union.
If something is unclear to you or if you are just looking for a second opinion, Unitron Regulatory offers advice on topics like:
We can also give presentations on regulatory subjects for e.g. your board, development team or conference.
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