medical device testing services

Medical Devices

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 safe and effective products.

With an intimate understanding of the Pharmaceutical and Medical Device Industries, Smithers Rapra has developed an extensive range of services to support the use of plastics, rubbers and other polymers in these challenging environments. 

Reduce risk and time to market

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 are UKAS Accredited (ISO 17025).
Our Extractables and Leachables Testing Laboratories are FDA Registered and operate to the principles of cGMP.

Smithers Rapra Expert Support and Testing for Medical Devices

product development and validation support for medical devices

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 expertise covers a wide range of testing areas including:

Extractables and Leachables testing 
With a focus on single-use / disposable components and systems, container closure systems and a wide variety for primary and secondary packaging, and other polymer usage in pharm, biopharm and medical device applications

  • Controlled Extraction Studies
  • Identification of Extractables
  • Leachable Profile Assessment

 

Medical Device Directive Support ​Guidance, preparation of technical files

  • Quality management systems implementation and auditing
  • Risk analysis and preparation of design and process FMEAs
  • Material selection, design control support
  • Long term data generation; (e.g. creep and fatigue performance)

 

Material Selection and Product Design 
Our materials expertise allows

  • Material selection and process optimisation
  • Reverse engineering
  • Material sourcing and supplier qualification
  • Accelerated aging studies
  • Durability testing

Medical Device Product Testing
PreFilled Syringes, Inhalation devices, Transdermal systems and Implants. Smithers provides a wide variety of ASTM and ISO standardised and custom tests, to qualify and register devices.  Our expertise includes mechanical testing of devices, dose accuracy, product integrity, shelf life stability, among other key characterisations to ensure performance, ease-of-use and reliability

  • Batch release testing
  • Generation of material data,
  • Pack integrity testing (e.g. bubble test, dye penetration, peel strength, leak detection, permeability)
  • Product and pack validation 

 

Manufacturing and Processing: Prototyping, small scale manufacturing

  • Process trials
  • Confidential compound development
  • Manufacturing feasibility reviews
  • Injection moulding flow analysis (Sigmasoft)

 

Pre-shipment testing, damage reduction, validation and qualification 

  • according to ASTM, ISTA, others international standards and bespoke solutions for clients.
Talk to an expert about your needs

Take advantage of Smithers Rapra and Smithers Pira’s extensive experience and knowledge in the development of standard and custom tests to demonstrate functionality and measure the performance of medical devices and packaging systems with respect to critical acceptance criteria.

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