Smithers Rapra provides concept to market support for Medical Devices. Whether you are looking for specific testing or more consultative support - our experts will help you develop and validate and safe and effective products.
Reduce risk and time to market
We can assist throughout your medical device product development cycle from concept, material selection, design for manufacture, manufacture, packaging (primary and secondary) through to the distribution testing for supply chain validation.
Our team is able to support product development up to the submission of design files to authorities, as well as assisting with the submission process itself. We can provide routine testing after product launch to ensure that your product always meets your critical acceptance criteria.
Smithers Rapra Expert Support and Testing for Medical Devices
Smithers Rapra and sister company Smithers Pira regularly work with clients developing drug delivery devices, single use systems, medical and pharmaceutical packaging. We provide expert technical and regulatory support. From routine materials testing to product or process characterisation and development, failure diagnosis or expert witness consultancy – we can help. Our experienced team will provide advice, guidance and recommendations as well as delivering test data and supporting global regulatory submissions.
Our laboratories at are ISO 17025 and UKAS Accredited.
Our Extractables and Leachables Testing Laboratories are FDA Registered and operate to the principles of cGMP.
- Material selection, durability assessment and testing
- Medical Device Directive services
- Extractables and leachables testing
- Medical device product testing
- Materials processing support
- Pre-shipment testing, damage reduction, validation and qualification
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