Batch Release Testing
Smithers Pira offers batch release testing services in accordance with Good Manufacturing Practices (GMP) across a range of medical devices including syringes, auto-injectors, inhalation products and aerosols.
Batch release testing is a requirement for medical devices exported within the European Community (EC) or European Economic Area (EEA) in order for them to hold marketing authorisation. At Smithers we understand the importance of working with a reputable partner who can provide regulatory compliant QC testing to a high standard and within a reasonable timeframe.
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:
- Packaging performance
- Device characterisation and functionality
Where product functionality falls outside the parameters of standard testing, we’re able to develop a bespoke testing programme to assess your product’s performance.
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