Our partnership with HEXApproach

We are pleased about the partnership with Peter Wellmann from HEXApproach



Peter Wellmann has been working in medical device development and product approval for 20 years. He now brings the experience of numerous projects in well-known companies to the newly founded company HEXApproach. He provides structured, transparent, personal and fast support through consulting, service and training. The main topics are QM systems, product development and technical documentation, CAD and work structure.

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.

You can find further information here.

With the BAYOOSOFT Risk Manager as the worldwide market-leading and validated software for the completely integrated creation of risk management records according to ISO 14971, HEXApproach has the appropriate tool in its portfolio. In a clearly structured environment, all relevant information is collected, stored centrally in an audit-proof manner and dynamically linked with each other in a fine-granular manner, thus simplifying and accelerating the creation of risk management documents many times over.

Would you like to learn more about the BAYOOSOFT Risk Manager?

Visit one of our webinars or contact us using the following contact form:


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