Medical Device Testing

MEDICAL DEVICES AND IVDS TESTING

Transform your innovative design into a reliable and marketable product with TÜV SÜD testing service

Transform your innovative design into a reliable and marketable product with TÜV SÜD testing service

meet regulatory compliance and achieve global acceptance

Medical device testing is a critical step in the process of transforming an innovative design into a reliable and marketable product.

At TÜV SÜD, our testing puts your product through a comprehensive medical devices industry assessment, and helps you demonstrate compliance with standards and regulations around the world.

Our tests cover your full design and production cycle - from prototype testing to CB certification and lab tests for ergonomics, electrical, mechanical and functional safety assessments, as well as software testing. We also conduct inspections of production facilities, environmental monitoring, and pre-shipment inspections, as well as testing for both active medical devices and IVDs and non-active medical devices.

List of Testing Services for medical devices & IVDs: 

Chemical / Biological Testing

  • Biocompatibility Testing
  • Microbiological Testing
  • Chemical Testing
  • Chemical Characterisation
  • Toxicological Risk Assessment
  • Genotoxicity Assessment and Evaluation
  • Sterility Assurance Testing
  • Reusable Device Testing
  • Biological Evaluation Plan

Cybersecurity Testing

  • Cyber Security Testing and Assessment Services
  • Medical Devices & IVDs Security Testing (Penetration Testing)

Physical Testing

  • Electrical Safety Testing
  • MRI Safety Testing
  • Functional Safety
  • EMC Testing
  • Environmental Testing
  • NRTL
  • IECEE CB Scheme

INTERNATIONAL LAB LOCATIONS: 

At TÜV SÜD, we combine expert medical product testing knowledge with a global network of internationally accredited laboratories and facilities, providing you with a one-stop solution. Our testing labs are based in:

  • China, Shanghai
  • India, Bangalore
  • Italy, Barberino Tavarnelle (FI) and Tito Scalo (PZ)
  • Singapore 
  • United States, New Brighton

Request for a quotation now!