Medical Engineering Technologies delivers excellence in combination device testing, globally.
Services include: biocompatibility and chemical characterization, dose delivery accuracy, extractable and leachable studies, formulation stability, mechanical performance, RLD comparisons, sterile barrier verification, human factors studies, and lots of good advice.
Medical Engineering Technologies is the destination for combination device batch release and design validation testing. Clients from across the globe have found our laboratory services to be rapid, precise, and very effective. MET has successfully delivered testing to medical device and pharmaceutical companies in over 20 countries across: Africa, Asia, Australasia, Europe, and the USA. We knowledgeably, reliably, and effectively deliver medical device and packaging validation, and we are a world-leading CRO for combination devices and prefilled syringes testing.
With accreditation to ISO 17025 for validation testing, and GMP for batch release testing, you can have complete confidence in the quality and accuracy of our results.
We only test medical devices, and we know about medical devices. Our technicians start with a product review and risk analysis. Then they can draw up a protocol. This may be for some quick verification testing or for a complete stability program. Project plans are also submitted to clients. We will feel like an extension for your team with our communication channels always open. Reporting may be at the end of a short project or at each stage of a longer study.
Physical performance and dose accuracy studies – A full suite of equipment along with knowledgeable technicians is available to meet your needs.
Extractables and leachables/ISO 10993-18 chemical characterization – With an ISO 10993-18 committee member on our team, we will always be up to date with all your testing needs.
Drug container compatibility, formulation stability – Our analytical chemistry laboratories work with combination devices at all stages of validation.
Design validation – Just check out our design validation guidebooks (available on request from our website) to confirm that we are leaders in developing validation/verification programs.
Batch release and importation testing – Fast turnaround work to previously agreed protocols reported with a certificate of analysis.
Human factors/Usability – Available for all delivery devices across multiple countries (summative or formative).
Find out why Medical Engineering Technologies is becoming the world-leading laboratory for combination device testing and why we are the best partner for supporting your product claims and regulatory submissions.
Posted Date: 11/30/2022
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