Development | Technicare

Research

All developments start with a customer request and thorough research. Our engineers extensively examine and analyze the needs, possibilities, and challenges. Multiple healthcare institutions are involved in the request to ensure that the idea is researched and tested across different settings. This helps us avoid the so-called "five-legged sheep" scenario. TechniCare develops only unique products that do not yet exist in hospitals but are applicable in multiple situations. The research process includes a macro analysis, an extensive market analysis, and a micro analysis. We carefully assess all applicable NEN and ISO guidelines, existing products on the market, and future trends for the product. Only in this way can we develop a product that is ready for the future.

Productgroepen

Design Proposal and Prototype

After multiple discussions, extensive analyses, and research, the design phase begins. In this phase, our engineers create 3D designs of the products to assess whether all proposed principles and solutions are viable. Once approved by the working group, TechniCare produces the prototypes in-house. These prototypes are developed for verification and testing, ensuring that all principles are thoroughly evaluated.

Productie

Verification and Documentation

Verification, validation, and documentation are carried out based on both prototypes and production series. Strength and force calculations, as well as other verification processes, are conducted using the prototypes. Verification and validation are performed in accordance with ISO 14971 and ISO 13485 standards. TechniCare prepares all documentation in compliance with the Medical Device Regulation (MDR). This includes user manuals, service manuals, and cleaning protocols, ensuring full regulatory compliance and safe implementation in healthcare environments.

TechniCare is gecertificeerd voor ISO13485:2016

Production

After completing and approving all phases, TechniCare is ready for production. Before starting full production, we always create a zero series (0-series) to conduct a final check on all aspects of the product. Once the 0-series has been validated, the production process is scheduled, ensuring a smooth and reliable delivery to our customers.

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