Even though the new medical device regulation EU 2017/745 has been postponed for a year, changing existing quality management systems (QMS) or building a new one in case of a previously lower risk class and for new ventures became a pressing issue for many entrepreneurs and quality mangement representatives. For new QMSs, it might be especially time-consuming to both prepare for the new medical device regulation EU 2017/745, but also still support the medical device directive 93/42/EEC as long as it is not yet replaced. We are working on many articles in the form of blog posts as well as an open book to support medical device manufacturers in regard to efficient and transparent medical quality management.
Today, we started two new things. First, we publicly began talking about our new approach for combining completely flexible adaptive case management with process automation and guidance - and present first results at the Tech Days 2020! Second, we initiated this blog.
At Pertuniti, regulated processes are performed within a case. The case allows managing tasks, documents, events, correspondence, and arbitrary data. Activity streams contain all manual and automated activities for your team and auditors. This way, we facilitate traceability, reduce documentation for audit trails, and allow project management within one system of record. Pertuniti introduces agility even for highly regulated organizations.