DESIGN CONTROL | RISK MANAGEMENT | SOFTWARE DEVELOPMENT

Our focus is on designing product development processes that are compliant to QSR 820.30, ISO 14971, IEC 62304 and are also efficient and effective.

The regulations provide a framework for deliverables and are also supported by many guidance documents. We take that framework and integrate it into your product development process so that compliance is assured.

For long term success, the process must be easy to teach, easy to learn and easy to use.



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