The regulatory requirements in medical technology place high demands on manufacturers. To meet these, solutions are knitted with hot needles. And always where it needed the most. The result is a construct of paralyzing constraints.
HEXApproach stands for a holistic approach to resolving these constraints. HEXApproach develops concepts and implements solutions for medical technology, product development, software tools and quality management. Special areas of expertise include risk management according to ISO 14791 and technical documentation for medical devices.
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