Medical Device Quality Assurance Through QMS

According to regulations, a medical device must be developed following the company QMS. We will help you through a step-by-step approach, to secure you are investing time in the proce-dures relevant for your current development phase.

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The Quality Management System (QMS) consists of policies, process descriptions and written procedures  applicable for your Medical Device, IVD or Combination Product. SDS has a holistic understanding of what parts are required, and when, during your product development journey, in order to assure you are taking the right steps in the right order for your QMS.

SDS MedteQ has extensive understanding of the required contents of your QMS, dependent on the type of product you are developing and manufacturing. We can help you with gap analyses, establishment of procedures, instructions and templates, executing internal and supplier audits and assuring regulatory compliance after possible audit findings.

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