Medical Device
Smither Medical Device Testing helps medical device and pharmaceutical product manufacturers bring innovative, compliant and highly regulated products to market with our world-class expertise and extensive independent medical device testing capabilities.
We support you throughout your medical device product development cycle, with medical device testing from concept, material selection, design and manufacture, packaging (primary and secondary) through to the distribution testing for supply chain validation.
Our expert team at our labs based in the UK, USA, and Germany will provide advice, guidance and recommendations as well as delivering tests to demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO.
Testing by Product
Comprehensive product-specific testing services for medical devices — covering implantables, diagnostics, drug delivery systems, and surgical instruments to meet FDA, ISO 10993, and EU MDR requirements.
Physical and Functional Testing of Drug Delivery Devices
Physical and functional performance testing for inhalers, syringes, auto-injectors, and other drug delivery devices — supporting design verification, regulatory submission, and quality control.
Chemical Analysis
Advanced chemical characterisation of medical device materials including polymer identification, additive profiling, contamination analysis, and elemental analysis to ISO 10993 and USP standards.
Healthcare Packaging Testing
Sterile and non-sterile healthcare packaging testing including seal integrity, burst, peel, and distribution simulation — compliant with ISO 11607, ASTM F2475, and ISTA protocols.
Medical Device Technical Consulting
Expert regulatory and technical consulting for medical device manufacturers — supporting MDR/IVDR compliance, FDA 510(k) submissions, risk management, and biocompatibility strategies.
Extractables and Leachables
Extractables and leachables (E&L) studies for drug-device combination products, container closure systems, and packaging materials to ICH Q3E, USP <661>, and ISO 10993-18 guidelines.
Medical Device Regulation (MDR)
Support for EU Medical Device Regulation (MDR 2017/745) and IVDR compliance — including technical documentation review, clinical evaluation support, and gap analysis against legacy MDD approvals.
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