Medical Device Testing & Assessment

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 and data security tests.. As required, we also offer inspections of production facilities, environmental monitoring and pre-shipment inspections.

Your Medical Device Testing and Evaluation partner for:

Implantable Active Medical Devices such as pacemakers, defibrillators and cochlear implants.
Active Medical Devices such as emergency medical equipment, diagnostic and dialysis equipment.
Non-Active Medical Devices such as cardiovascular devices, soft tissue and orthopaedic implants, ophthalmological and dental devices, wound care products, instruments and hospital consumables.
Rehabilitative Medical Devices such as wheelchairs and crutches.

Our services at a glance

Area	Services
Biological and Chemical Testing for Medical Devices	Cytotoxicity Skin sensitisation Irritation Systemic toxicity Genetic toxicity Implantation Haemocompatibility Sterility tests USP pyrogen test Bacterial endotoxin LAL test USP Class I – VI plastic classification Bacterial filtration efficiency Bacteriophage penetration Impermeability to microorganisms Chemical composition and characterisation Impurities, lubricant content Ethylene oxide residues Reducing (oxidisable) matter Acidity or alkalinity Residue on evaporation / on ignition UV absorption Degradation products from polymeric, ceramic and metallic materials Leaching and migration tests Leachable protein from medical gloves Penetration resistance against chemicals / synthetic blood Permeation rate of chemicals and therapeutic drugs Surface morphology and microstructure Corrosion resistance Shelf life studies
Active/Electrical Medical Devices Electrical Testing	Usability testing RoHS testing PAK Environmental testing HALT/HASS Battery testing Mechanical testing Ultrasound testing Performance testing of infusion pumps Radiation protection testing EMC testing IEC 60601-1-2 3ed Telemedical testing
Active/Electrical Medical Devices Functional Safety & Software Safety Approval/Testing	Functional safety approval IEC 60601-1 3ed IEC 61508 Programmable Electrical Medical Devices IEC 60601-1-4 Software lifecycle IEC 62304 Usability and human factors IEC 60601-1-6 3ed
Active/Electrical Medical Devices Design Dossier Assessment	Functional safety Performance Electrical safety Biocompatibility Electromagnetic compatibility Electrical safety Mechanical safety Protection from ionising/non-ionising radiation Environmental aspects Usability Hygiene Packaging
Non-Active Medical Devices Design Dossier Assessment	Performance and safety assessment according to relevant product standards Biocompatibility assessment (biological evaluation according to EN ISO 10993) Assessment of sterilisation validation (ethylene oxide, moist heat, irradiation, aseptic processing, special sterilisation methods, virus inactivation) Assessment of sterile packaging validation (EN ISO 11607-1/-2, ASTM F 1608) Assessment of Risk Management (EN ISO 14971) Assessment of Risk Management specifically for devices utilising tissues of animal origin Assessment of safety of medical devices using human blood derivatives and tissue engineering Environmental aspects Labelling requirements Usability

Your benefits at a glance

Improve your process quality and transparency
Ensure quality, safety and performance of your devices
Raise brand reputation and consumer trust and satisfaction
Avoid costly product recalls by delivering consistent quality and safety