Medical Devices
As a leading independent materials testing, analysis and consultancy organisation to the medical device industry, Ceram's knowledge of products, packaging, materials and chemistry is both extensive and diverse in the field of medical device testing.
What's more, Ceram is leading the way in materials innovation by developing a portfolio of new materials and technologies for its clients, such as novel bioceramic materials and new multi-element substituted hydroxyapatite.
From initial concept and design, through to manufacturing consultancy and after-use evaluation, Ceram has worked to assist in the development and improvement of a wide range of medical devices and medical equipment including:
- Vascular devices and access systems such as stents and catheters
- Orthopaedic implants, explants and instruments
- Biomaterial, grafts, cements, foams, powders and putties
- Dental materials, products and dental instruments
- Drug delivery products and systems
- Wound care products
- Microelectronic implants
- Diagnostic and monitoring equipment
- Packaging and packaging materials.
working with materials such as:
- Polymers & elastomers
- Ceramics and advanced ceramics
- Metals & metal alloys
- Minerals
- Fabrics
- Electronics & semiconductors
- Composites.
We undertake medical device testing, analysis and consultancy for medical device manufacturers throughout all stages of the product lifecycle including:
Concept, Prototyping & Materials Formulation
Our knowledge of material formulation and its effect on chemical and physical performance of devices, and our understanding of the passivation of surfaces with coating technologies, coupled with modelling and small prototyping facilities, make us uniquely placed to accelerate new product development projects.
Pre-Clinical Evaluation
Pre-clinical evaluation and selection of materials, coatings and medical packaging for new products is critical to medical device manufacturers and forms part of applications to regulatory authorities.
Processing & Manufacturing Support
We offer quality assurance programs, cleanliness validation and failure analysis for the medical device manufacturing process. We can also advise on the refinement of the manufacturing process, leading to more efficient production processes and better end-products.
After-Use Evaluation and Failure Analysis
We can work closely with you to test, assess and evaluate medical devices after use to improve future product design and, where failure of the device has occurred, to identify reasons for failure such as, contamination, wear, fracturing, cracking, disbondment.
Ceram is now able to conduct testing on zirconia medical device implants to ISO 13356:2008. The standard covers a diverse range of aspects including density, chemical composition, grain size, phase composition, strength, fatigue, radioactivity and accelerated ageing. The standard also covers requirement limits for medical applications.
Case Studies:
Cleanliness Validation of Orthopaedic Implants for Joint Replacement Instrumentation Ltd
Surface contamination investigation
