We have been busy compiling successful submissions of Class III, IIb and Ir technical files with approval under MDR of ISO 13485 QMS and the design and manufacture of custom implants. MDR needn’t be a minefield when you use it and apply it successfully – though there is a lot to do and understand. Here are a few tips which we have found useful:-
Good planning for legacy products...Read More
We have been successful in securing a grant from Medilink East Midlands for the continued development of Limbcast and Limbmat. These novel treatments of fracture management for the emergency services will provide lower cost splinting and immobilization of the patient to the hospital with the advantage of a compact and flexible system.
With continued investment to provide better prototyping facilities reducing the time and cost from design to manufacture an RF welding capability has been included which will allow welding PVC and TPU films. This compliments the existing 3D printing, laser cutting capabilities and will allow better products to market faster.
……. After – 2 weeks
Completion of a new purpose built cleanroom facility for cleaning and packaging of medical devices. Fruition provided the design and project managed the build which was completed in 2 weeks with minimal impact to the existing manufacturing. This project demonstrates how under utilized space can be transformed providing additional manufacturing...Read More