My focus and interest is on how to combine Lean and Agile methods with regulatory expectations for Medical Device software. see a great potential to gain quality and productivity picking the best practices from Lean and Agile.
[show_more =”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.” less=”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.””]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 [/show_more]
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.