A crucial part of the manufacturing process is quality. Regular product quality tests are rigorously applied by Orthoplastics to ensure compliance with industry standards. Regulatory and compliance testing is performed in Orthoplastics own onsite laboratory that is UKAS accredited, and the majority of its projects are carried out in accordance to ISO17025.
It’s commitment to research and development is unrivalled within the orthopaedic implantable plastics industry, providing a depth and breadth of technical expertise to support all product development programmes.
Orthoplastics’ industry leading laboratory facilitates the materials characterisation for; material suppliers, processors, manufacturers and end users in addition to research and development.
Consulting with its clients, referring to the applicable standards and their extensive experience, it designs test programmes to meet the requirements for applications such as CE and 510k submissions. The quality systems employed at Orthoplastics meet the highest standards required within its main service sector, namely implantable medical devices.
Orthoplastics research and development laboratory is comprehensively equipped and has extensive experience of testing materials and products manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), Polyether ether ketone (PEEK) and other polymers primarily within the medical device sector. In addition to the essential equipment for certification the research and development laboratory is equipped with the following:
Orthoplastics have a very robust quality accreditation system in place to meet the demands and needs of its customers. They exceed the demands of regulatory accreditation right from basic quality standards through to laboratory standards, so that all the regulatory bodies across the world have confidence in the data that Orthoplastics generate.
The manufacturing quality control systems which Orthoplastics have been proudly accredited to are as follows: