Together we bring your medical products to the world market, meet international regulations and guarantee product quality and safety.
The introduction of a quality management system according to EN ISO 13485 often marks the beginning of the world of the medical device industry.
The approval of medical devices is a complex subject that covers a multitude of areas and poses a challenge for those placing medical devices on the market.
The clinical evaluation is an essential part of the technical documentation and a prerequisite for the fulfilment of the Essential Requirements.
MDSS Consulting GmbH will analyse with you your existing documentation and demonstrate to what extent you must become active in order to fulfil the new requirements. Based on a gap analysis we will identify the discrepancies between the actual state within your organization and the target criteria of the legal requirements of the MDR or IVDR - while maintaining your present company policy.