Elevate your medical device testing to global standards
Non-active medical devices must be tested against the highest standards to ensure they cause no unintended harm and are fit for purpose. Testing of non-active medical devices involves analysis of the product for chemical residues, leaching and other potentially harmful factors. Professional technicians put your non-active medical devices through a series of tests to ensure they are safe to use.
Testing non-active medical devices is a crucial part of the product development life cycle. It helps:
TÜV SÜD has long experience of testing and analysis of non-active medical devices. We offer a broad range of testing services including biological, chemical, mechanical and physical testing. TÜV SÜD also has the capability to provide chemical characterisation services for medical devices and components, as well as services for analysis for extractables/leachables and chemical residues.
TÜV SÜD also provides contamination diagnosis services and shelf-life studies in addition to microbiological tests for medical devices such as bioburden, sterility and endotoxin LAL tests. We have the expertise and specialisation to conduct biocompatibility tests in compliance with GLP principles as well. And we also test non-active implantable medical devices.
In addition to product testing, we provide other relevant services for manufacturers of non-active medical devices, including certification of sterilisation processes and cleanroom certifications.
Work with TÜV SÜD for a comprehensive non-active medical device testing service. Our process typically involves:
We understand that time to market is a key consideration for medical device manufacturers, and so TÜV SÜD offers expedited testing programs. Contact us today to learn more.
Through a series of webinars, we will review major impacts introduced by regulation EU 2017/746
Through a series of webinars, we will review major impacts introduced by the regulation EU 2017/746.
Fulfill requirements of Annex I to the MDR
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