Reduce Risk and Time to Market
From simple dressings to sophisticated life-support products, medical devices play a crucial role in disease diagnosis, prevention, management and monitoring. Smithers Rapra and sister company Smithers Pira provide concept to market support for medical devices. Whether you are looking for specific testing or more consultative support – the expert team will help you develop and validate and safe and effective products.
The team 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.
We can support product development up to the submission of design files to authorities, as well as assisting with the submission process itself. We also provide routine testing after product launch to ensure that your product always meets your critical acceptance criteria.
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. Our UK Laboratories are UKAS Accredited (ISO 17025) and our Extractables and Leachables Testing Laboratories are FDA Registered and operate to the principles of cGMP.
The teams provide expert technical and regulatory support from routine materials testing to product or process characterization and development, failure diagnosis or expert witness consultancy. Experienced scientists will provide advice, guidance and recommendations as well as delivering test data and supporting global regulatory submissions.
Support for designers and developers of medical devices includes:
- 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
Visit Smithers Rapra for an overview of services offered by both companies
Independent Market Insights
Smithers Rapra market reports provide an authoritative and expert view of which emerging markets, technologies and factors will affect your industry in the future. Recent topics include the future of high performance plastics, thermoplastic elastomers and prefilled syringes. These independent studies help you identify new business opportunities using quantitative market forecasts and employ a detailed breakdown of market sizes to plan future strategy with confidence.
More about Market Insights
Smithers Rapra is also a renowned technical publisher, with a range of titles and an extensive polymer database offering practical and scientific know-how on all aspects of rubbers, plastics and polymer-based composite materials.
Visit Smithers Rapra Bookstore
Smithers offers “Best in Class” quality management certification services specifically designed for the medical device industry. Our clients come to us seeking auditing services from an accredited quality management systems registrar that demonstrates a great deal of technical knowledge. We offer certification services for ISO 13485, as well as other related quality management system standards.
Visit Smithers Quality Assessments