The field of health technology as business – TELI
The aim of the TELI project is to promote the business prerequisites of Finnish health technology companies. This target will be achieved by studying the problems in the field from the perspectives of both the business value chain and field-specific requirements. Ten companies, the well-being federation of the municipality of Forssa and the City of Hämeenlinna are involved in the project.
In 2015, the international quality standard ISO 13485 for medical device manufacturers underwent a fundamental change. So far the quality system has focused on product development and production, but the new version of the standard requires much more from all sections of the quality system, covering the entire life cycle of products from purchasing raw material and components to marketing and aftercare. Decree proposals of the EU are still being developed, but the decrees will completely change the regulatory scene of medical devices and preparations for the changes must begin early enough. Taking the new ISO 13485 requirements and new decrees of the EU into account in time will generate significant cost savings for companies and at best, create a competitive advantage compared to slower companies. The project ensures anticipating and interpreting the changes, and investigates the implementation of needs for change and possible problems faced by the companies.