Teste & evaluări pentru dispozitivele medicale

Undergoing tests is a critical step in the process of transforming an innovative design into a reliable and marketable product

At TÜV SÜD, we combine expert knowledge with a global network of nationally accredited laboratories and facilities. This enables us to provide customers with a one-stop testing solution. Tests that will help you to demonstrate compliance with standards and regulations wherever you are in the world.

Our tests cover your full design and production cycle. From there, we see your products through from prototype testing to CB certification and laboratory tests for ergonomics, electrical, mechanical and functional safety plus software tests. As required, we also offer inspections of production facilities, environmental monitoring and pre-shipment inspections.

Approval of Active Medical Devices

Approval of Active Medical Devices
Design Dossier Review
CE marking of Medical Devices (93/42/EEC)
WEEE Directive
RoHS Directive
R&TTE Directive (99/5/EC)

Testing of Active Medical Devices

Testing of Active Medical Devices
IEC 60601
Functional Safety in the Medical Industry
NRTL Testing
IECEE CB Scheme
EMC Testing
Environmental Testing
ISO 14971 Risk Management

Approval of Non-Active Medical Devices

Approval of Non-Active Medical Devices
CE marking of Medical Devices (93/42/EEC)
Medical Devices with Materials of Animal Origin
Approval of Drug/Device Combination Products

Testing of Non-Active Medical Devices

Testing of Non-Active Medical Devices
ISO 10993-1 Biological Evaluation and Biocompatibility Testing
Biological, Physical and Chemical Testing of Medical Devices
ISO 14611 Cleanroom Environments for Medical Devices
Sterilisation Practices Control and Validation