ENSURE MEDICAL DEVICE SAFETY THROUGH BIOLOGICAL, CHEMICAL AND PHYSICAL TESTING
A medical device or material used in a medical device that comes in direct contact with a patient must be able to perform its intended function without inducing significant rejection or adverse reaction in a patient. The degradation or leaching of chemicals and other device materials may lead to deleterious effects on a patient, and potential adverse reactions can range from the rejection of the device by the body to longer term reproductive or developmental effects.
For these reasons, medical devices and materials are typically subject to a range of biological, physical and chemical tests to ensure that the benefits offered by the device exceed any potential risks to a patient as a result of the device itself or the materials used in the device.
CHEMICAL, PHYSICAL AND BIOLOGICAL TESTING OF MEDICAL DEVICES
The chemical analysis of a medical device generally includes a wide range of tests and product evaluations. Testing can include tests for chemical compositions as well as tests to determine the potential for extractable or leachable materials or residues that are not intended to be part of the chemical composition but are present as a result of manufacturing processes. Additional chemical tests can include performance requirements, such as resistance to corrosion, permeation rates for chemicals, and anticipated shelf-life studies.
Physical evaluations generally involve tests for the physical strength of a device (such as tensile strength and elongation) and physical performance characteristics (including force at break and resistance to leakage), as well as tests for product shelf-life.
Biological evaluations address a device’s biocompatibility, and can also include biological performance tests such as resistance to bacteriophage, impermeability to microorganisms and bacterial filtration efficiency.
WHY CHOOSE TÜV SÜD MALAYSIA
TÜV SÜD Malaysia laboratories offer a comprehensive range of chemical, physical and biological testing services in accordance with applicable international standards. In addition, TÜV SÜD Product Service’s industry specialists and clinical practitioners have extensive experience with all types of medical devices.
OUR SERVICES AT A GLANCE
- GLP-compliant biocompatibility evaluations - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
- Risk management expertise - TÜV SÜD Product Service and TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971, and conduct thousands of in-depth risk management audits each year.
- Cleanroom/ISO 14644 expertise - TÜV SÜD is a single source for manufacturers seeking global regulatory review and approval of environmentally-controlled device manufacturing and production facilities. In addition, TÜV SÜD Industry Service’s Clean Cert Program provides support in the design, construction and testing of cleanrooms.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- FDA 510(k) third party review service - TÜV SÜD Product Service has participated in the FDA 510(k) third-party review program since its inception in 1996, and offers third-party submission reviews for over 600 devices. TÜV SÜD medical device experts maintain close contact with FDA reviewers to ensure that issues are promptly addressed, resulting in a more efficient review process and timely product clearance.
- Other testing and certification services - TÜV SÜD Product Service can also provide compliance testing for medical devices in accordance with other relevant regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC).