The IVDR reinforces the need for clinical evidence to demonstrate conformity with the relevant
general safety and performance requirements.
A Technical File is proof that a medical device complies with the essential
safety and health requirements set down by the relevant Directive(s).
GiDoS SPRL is a quality driven, service-oriented regulatory affairs company, located in Brussels, Belgium.
We believe in creating a safer marketplace through compliance and regulatory actions. With more than 500 million users in Europe, the compliance of your products and the safety of consumers are essential. We are here to secure both.
What we can help you with
Clinical Evidence & Performance Evaluation
Performance evaluation of a device is a continuous process by which data are assessed and analysed to demonstrate the scientific validity stated by the manufacturer.
Technical Files are required for all classes of medical devices – Class I, Is, Im, IIa, IIb, III – and they must hold essential information about the medical device, including photographs and diagrams
Get in Touch
Any questions? Contact us, we will be happy to get in touch with you!