Non active medical devices, Non-active Implantable Medical Device Effective date: 12 DEC 2018 © TÜV SÜD AG | V-M/MHS/WEB/32.1/en/SG

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Testing of non-active medical devices

Undergoing tests is a critical step in the process of transforming an innovative design into a reliable and marketable product

WHAT IS TESTING FOR NON-ACTIVE MEDICAL DEVICES?

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.

WHY IS IT IMPORTANT TO TEST NON-ACTIVE MEDICAL DEVICES?

Testing non-active medical devices is a crucial part of the product development life cycle. It helps:

• Provide independent analysis which can reveal design faults
• Assure buyers and regulators that the product is safe
• Offer certainty that the product is fit for market
• Provide evidence that your company has carried out due diligence
• Reduce the risk of expensive civil litigation

TÜV SÜD IS A GLOBAL LEADER IN NON-ACTIVE MEDICAL DEVICE TESTING

TÜV SÜD has long experience of testing and analysis of non-active medical devices include blood bags, infusion sets, syringes, catheters, condom, contact lens, gloves, stents, procedure kits, contact lens solutions etc. 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, cleanroom certifications, products stability, packaging integrity and transportation performance.

TÜV SÜD’S NON-ACTIVE MEDICAL DEVICE TESTING SERVICES

Work with TÜV SÜD for a comprehensive non-active medical device testing service. Our process typically involves:

• Requirements gathering
• Extensive tests at our state-of-the-art laboratories around the world
• Analysis, reporting and recommendations
• Certification as appropriate

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.

ACCREDITATION AND RECOGNITION

TÜV SÜD laboratories are accredited to the requirements of ISO 17025 by the Singapore Laboratory Accreditation Scheme (SAC-SINGLAS).

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