Services
Technical Files
We can compile your full technical file to meet the requirements of the new Medical Devices Regulation EU/2017/745.
We can also help you create or update your existing quality system to the
ISO 13485:2016.
Manufacturing and Testing
We can help you with sourcing manufacturing contractors, product testing and sterilization services.
Small Projects
Small Projects
Do you just need parts of a technical file completing or updating? For example clinical evaluation plans, reports, usability reports, post market surveillance etc. these are all individual services we also offer.