Quality & Compliance
Medical Device Regulations
Medical devices operate under the most demanding regulatory framework of anything we manage. There are no shortcuts in the technical documentation.
What's included
Medical Device Regulations
Medical device risk classification
Verification of specific medical CE marking
Review of the technical file and declaration of conformity
Checking the manufacturer's quality management system (ISO 13485 where applicable)
Guidance on the EU Authorized Representative requirement
Frequently asked questions
About this
Do you handle any medical device risk class?
We assess each case; documentation complexity increases with the risk class.
Is an EU Authorized Representative mandatory?
It depends on where the manufacturer is established; we confirm this as part of the initial assessment.
Do you work with in-vitro diagnostic devices?
Yes, under the specific regulatory framework that applies to them.
Quality & Compliance