Services

PROCESS

PRODUCTIVITY

RESULTS

DESIGN CONTROL / RISK MANAGEMENT / SOFTWARE DEVELOPMENT

COACHING  GUIDING  TRAINING

MEASURING SUCCESS

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 provides a framework for deliverables and are also supported by many guidance documents.  We take that formwork 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.

When your teams are at their peak performance they are in genius and will develop processes that will be compliant but will also work for them. The processes will be adopted quicker, refined, improved and operate at high efficiency and effectiveness. We coach, guide and train your resources to be at their peak performance, during the process of developing new ways of operating,  delivering the results your company needs.

We believe compliance can be strongly linked to profitable growth. Creating metrics is a key to establishing this link and also providing guidance to teams on their continuous improvement journey. We work with you to create metrics directly related to adoption of the new product development process and the compliance achieved. Bringing products to the market on time, at the right quality level is critical to achieving profitable growth.

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