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You need a system to guarantee good quality

The WILD Group’s certified quality management system guarantees a short time to market for your products and regulatory certainty for audits and inspections.

These are medical technology products that save lives and maintain or restore people’s health. It is therefore understandable that the quality of all medical technology equipment must meet the most stringent criteria. This industry is highly regulated and characterised by various product and registration requirements. One of the key requirements is the development and implementation of a fully certified quality management. WILD introduced such a QM system already back in 2010 and has been registered as an FDA-compliant contract manufacturer ever since. As a result, the systems partner has several years of experience with the mechanisms and rules that must be observed. “We guarantee the highest functional, safety and quality standards. In every project phase, our customers can be sure that all processes comply with the required rules”, says WILD CEO Josef Hackl.

The latest rules, such as those regarding usability and software, are taken into account already during the development of a product. This was also the case with the Biochemistry Analyser, an innovative device used for in-vitro diagnostics. “We permanently integrated the necessary processes such as the standard-compliant collection and documentation of requirements and the software design for medical products in accordance with IEC 62304, already in the development process”, Development Manager Markus Poßegger explains. WILD also supported its customer in risk management and actively collaborated in the process of identifying dangerous situations.

The most recent audits, in which our customers scrutinised all procedures from order intake to delivery, demonstrated that WILD maintains the necessary insight into the maze of standards and that all our processes meet the highest requirements. Their conclusion: WILD scores between 98% and 100% of the achievable points in all Areas!