Smithers offers testing to support batch release of medical devices based on functional requirements of the device or its packaging. Our experts have a wealth of experience in physical device testing, materials testing and chemical analysis and can provide you with a comprehensive overview of your product’s performance.
Supported by our state-of-the-art device testing facilities, our batch release testing capabilities include:
- Testing performed following approved validated methods
- Sample Traceability – from receipt to conditioning, testing, destruction or return
- Generation and Control of CoC or CoA
- Independent QA release of test certificates
- Agreed data governance
Quality management system conforming to ISO 17025, EU GMP and FDA regulations 21 CFR Parts 210, 211.
Should product functionality fall outside the parameters of standard testing, at Smithers we are happy to work with you to develop a bespoke testing program, to assess your product’s performance.
Supporting Consistent Product Performance
Batch release testing provides manufacturers with ongoing data on the functional performance of medical devices and their packaging. Smithers can work with manufacturers to establish testing programs aligned with defined product requirements, helping identify changes in performance between batches and support consistent product quality throughout production.
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- Drug Delivery Device Test Capabilities
- Batch Release Testing
- Custom Test Method Development
- Infusion Pump Testing
