Very stringent regulations are in place to ensure health and safety of patients with respect to medical products.
Medical devices require CE marking, which indicates they comply with applicable European Directives, prior to placing on the market. In medical device industry, implementation of the ISO 13485 quality management system (QMS) is a widely accepted tool to achieve compliance with legal and regulatory requirements. This standard provides a streamlined management system including processes to run consistent product design and development processes.
With a growing number of projects which will develop medical devices, Wyss Zurich is implementing product development processes on the basis of the ISO13485 standard. Adoption of these quality procedures will ensure that product development activities performed at Wyss Zurich are valid for the CE-marking process, thereby expediting market entry of developed medical devices and provide a competitive edge.
At the Regenerative Medicine Platform, the quality procedures for medical device development will complement the existing Good Manufacturing Practices (GMP) QMS for preclinical development and clinical investigation of medicinal products, thereby providing the regulatory backbone and expertise for a broad set of projects.