Global Leader in Medical Device Testing
Medical device testing means more to us than numbers and standards. At TÜV SÜD, we know that every device we test may be used to save a life. That is why we hold the highest regard for the medical device industry. We have tested thousands of products that have gone on to play an integral role in the medical field.
As one of the leaders in medical device testing, we offer a wide range of testing and assessments. One of our key areas of focus is our expertise in high-risk surgical robots and infusion pumps. The caliber of knowledge we hold on these topics ensures the trust our clients are looking for in a testing partner.
TÜV SÜD’s global team of over 750 healthcare and medical device testing experts, engineers and medical doctors are well positioned to help your testing run smoothly, stay informed about the new regulatory requirements, and best prepare your device to reach market quickly.
Non-active Medical Devices
- ISO 10993-1 (Biological Evaluation and Biocompatibility)
A medical device that must contact the patient physically must be tested for both short and long-term biological compatibility. As a top medical device testing provider, our abilities include GLP-compliant biocompatibility testing in accordance with ISO 10993 standards. We also assess the compliance of regulatory requirements for medical devices in major medical device markets. Read more
- Biological, Physical and Chemical Testing for Medical Devices
Expanding off of biological standard is the comprehensive overview of all biological, physical and chemical reactions of a medical device. From a thorough assessment, we can customize testing to your medical device, and assess the correct regulations and functional safety are in place. Due to our expanded laboratories, we can do all testing under one roof. Read more
- Sterilization Practices Control and Validation for Medical Devices
A key element of medical device production is ensuring the sterilization of the device. Since sterilization is technically complex, many manufactures find maintaining the appropriate process and controls a challenge. We not only test and certify to ISO 11135, 11137, and 17665, but we also review documentation prior to submissions and audits of quality management systems. Read more
Learn more about our testing services for non-active medical devices:
Active Medical Devices and IVD Equipment
- IEC 60601-1
The IEC 60601-1 (Edition 3.1) is the widely accepted set of technical standards that are in place to determine the quality and safety of medical electrical equipment. We provide a one-stop-shop for testing and certification to the IEC 60601-1 standards. Read more
- Functional Safety in the Medical Industry
Functional Safety in the medical industry is vital to the patient’s well-being. We assess functional safety in multiple ways throughout the entire lifecycle of a medical device production. This helps keep people and the environment safe, and mitigate risk for your product. Read more
- Cyber Security Testing and Assessment Services
Cyber Security must be ensured for medical devices, as failure to protect data means a breach in patient confidentiality, and has the potential to result in death or severe injury. We provide assessments and testing to confirm data security, and can customize a plan to your medical device’s needs. Read more
- EMC Testing
Electromagnetic compatibility (EMC) testing gauges the device’s capability to function as it should in the electromagnetic environment it is in, without an intolerable electromagnetic reaction. We offer a wide array of EMC testing and certifications for all components of devices. Read more
- Environmental Testing
Environmental testing for medical devices is a key element to establishing lifelong quality and safety. Environmental testing places a device in extreme conditions to determine weaknesses in design or performance. Our cutting-edge facilities and labs allow us to provide a comprehensive list of environmental testing. Read more
As an accredited Nationally Recognized Testing Laboratory (NRTL) certifier, we are given special recognition in the United States and Canada for independently certifying products that adhere to the Occupational Safety and Health Administration (OSHA) and the Standards Council of Canada (SCC). Read more
- IECEE CB Scheme
We are proudly a national certification body under the IEC System for Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE) Certification Body (CB) Scheme, which is a system of acceptance of product safety test reports and certificates for electrical and electronic equipment, devices and components. Our CB testing labs test medical device products under nearly all 19 CB Scheme product categories. Read more
Learn more about our testing services for active medical devices and IVD equipment:
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