Development | Technicare

Research

All developments start with a customer request and thorough research. Our engineers extensively analyze the wishes, possibilities and challenges. Several healthcare institutions are involved in the request, so that the idea can be immediately researched and tested within different institutions. In this way we avoid the so-called 'sheep with five legs'. TechniCare exclusively develops unique products that do not yet exist in hospitals, but are applicable in multiple situations. The research includes a macro-analysis, a comprehensive market analysis and a micro-analysis. This involves careful consideration of all applicable NEN and ISO guidelines, existing products on the market and the trends and future of the product. Only in this way do we develop a product that is ready for the future.

Products

Design proposal and prototype

After several discussions, detailed analyses and research, the design phase follows. Our engineers design the products in 3D to verify that all the principles and solutions thought out can actually work. After approval from the working group, TechniCare produces the prototypes in-house. These prototypes are produced as verification and test to thoroughly evaluate all principles.

Productie

Verification and documentation

Verification, validation and documentation take place based on the prototypes and production runs. Verification, strength and force calculations and the like are performed based on the prototypes. Verification and validation are done in accordance with ISO 14971 and ISO 13485. All documentation is prepared by TechniCare in accordance with the Medical Device Regulation, including user manuals, service manuals and cleaning protocols.

TechniCare is gecertificeerd voor ISO13485:2016

Production

After going through and agreeing to all phases, TechniCare is ready for production. Prior to the production runs, TechniCare always prepares a 0-series so that everything is checked one last time. After the 0-series, production is scheduled so that deliveries can be made to customers.

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