Services

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.

We can help you with sourcing manufacturing contractors, product testing and sterilization services.

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.