Regulatory roadmap - 3D X-ray microscope for clinical pathology

Important results from the project

** Denna text är maskinöversatt ** The project intended to increase competence for the activities required to be able to CE mark a product on the clinical market. All disciplines within the company have participated and, in addition to increased understanding, we have received concrete tools and data to work with in the future. The goals of defining intended use, planning for a quality management system and laying out a regulatory roadmap have been met - while we have understood the effort the work itself requires.

Expected long term effects

The result of the project is definitely that we have understood the effort required to bring a product to the clinical market. We have also understood that it is possible to parallelize the work if we only set the right conditions from the beginning. Concretizing and narrowing down the clinical benefit in the first release of the product makes the project realizable and predictable. Getting help at various stages of the work is necessary. A quality management system for a medical device must be certified by an external "notified body" and then we must follow it in our operations.

Approach and implementation

The arrangement has been that the consultant has prepared the basis for the various sub-activities and in workshops conveyed and discussed various aspects. The team then worked independently to produce results and presented them at the next opportunity. This iterative work has led to lasting knowledge. The company´s employees are now well-versed in the requirements that are set for bringing a medical device to the market and how these eligibility requirements can be met. The management has also gained an understanding of which resources must be added in the upcoming work.