A Technical File is proof that a medical device complies with the essential
safety and health requirements set down by the relevant Directive(s).
Find all Medical Device Regulations MDR & IVDR
We are here to create your Technical File.
Any questions? Contact us, we will be happy to get in touch with you!
T: 32 (0)2 732 72 92
GiDoS SPRL is a quality driven, service-oriented regulatory affairs company, located in Brussels, Belgium. Our main service area is in the medical sector, with a focus on Medical Devices and In-Vitro Diagnostics.
>> OUR INDUSTRIES
- Medical Devices
>> OUR SERVICES
- Technical file
- Clinical Evidence
- Risk management
- Borderline classification
- Gap assessment