Developing new medical innovations that are effective and safe for patients is advanced, time-consuming, and costly. It often takes many years and is a demanding process because the product, in addition to having to work, also has to be safe and suitable for large-scale production. The industry is heavily regulated, with requirements and standards to comply with and authorities that make decisions on approval of new products for the market.
Another major challenge is to create efficient and user-friendly ways of working, while meeting the requirements of both authorities and clients. Many fail to create a management system where it is easy to find, manage and maintain documents, procedures, cases and processes. This often leads to unnecessary administration, reduced transparency and overview, increased risk, and difficulties in meeting requirements.