Medical device manufacturers are obliged to set up a quality management system and provide evidence that their medical devices fulfil the safety and quality requirements. Proof of quality assurance must also be provided for all machines, tools and the entire manufacturing process. In addition, manufacturers of medical devices must also check the quality management systems of their suppliers. The regulatory framework for implementing these requirements is set out in corresponding guidelines and standards: For example, ISO 13485, ISO 14971, MDR, MDSAP or even CFR Part 11.

Common procedures for validating software are usually a considerable burden due to their complexity, the effort involved, the amount of paper, the lack of practical benefits, etc. For this reason, small and medium-sized companies in particular shy away from the urgently needed introduction of software requiring validation.

QSC has a tried-and-tested methodology based on GAMP5 that is specifically geared towards the introduction of standard application software. Our process-based approach is combined with an innovative, risk-based approach and, despite validation, enables you to introduce QS1 quickly, easily and cost-effectively.

In the context of QS1, configurable standard software means no customisation of interfaces and functions. Compared to conventional validation procedures, our risk-based approach reduces the effort required for test planning and execution by more than 50%.

The validation methodology is customised to your specific operational context during the project and integrated into existing QM processes such as your change control procedure. Release changes are easy for you to manage with our validation repository and can be carried out promptly based on changes with little effort.