Pre-Clinical Evaluation
The evaluation, verification, and validation of medical device design through pre-clinical and early feasibility medical device testing is a critical part of the regulatory process. Pre-clinical evaluation and selection of potential suppliers of materials, coatings and packaging for new products is an important part of the process.
Ceram’s expertise in materials and our knowledge of material, surface and chemistry analysis technologies allows us to assist customers in the development of biomatierals and medical devices.
We are able to:
- tailor test methods to test for specific performance criteria
- measure physical & chemical properties
- conduct material characterization analysis
- aid the selection of materials
- add value to developing quality assurance programs, both for medical devices and input materials.
Some of the projects we have been involved in include:
- An XPS investigation of active loading on drug powders for Dry Powder Inhalers (DPIs)
- Pre-clinical evaluation – catheter balloons
- DSIMS analysis of drug X containing polymer-coated stents.
Development & Sourcing of a New Glass Material for Mansol Preforms
Testing & material trials
Cleanliness Validation of Orthopaedic Implants for Joint Replacement Instrumentation Ltd
Surface contamination investigation
Plasma Treatment of Inhaler Cans for Bespak
Investigation of plasma deposition of a surface modifier in inhaler cans
