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Medical / Health Care / Pharmaceuticals

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My focus and interest is on how to combine Lean and Agile methods with regulatory expectations for Medical Device software. I see a great potential to gain quality and productivity picking the best practices from Lean and Agile. These techniques can contribute to high quality, usability, safe architecture in combination with short time-to-market for new products and features. We need of course to use the techniques correctly. Risk Management is central in the regulatory expectations. It can be challenging to make it work in a software department. The basis for efficient software validation is a solid and efficient Quality Management System. Proper IT infrastructures make things much