Quality Assurance & Medical Device Documentation

During product development of a Medical Device, IVD or Combination Product, the thinking "if it was not documented, it did not happen" is a valuable mission. We will guide you through securing your product documentation compliance.

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Regulations require product development steps to be documented, to secure user safety and the product efficacy is in focus. Taking advantage of SDS Life Science’s strong expertise in quality control for product development, we can provide guidance on how you can assure product documentation compliance.

For most Medical Device, IVD, and Combination Product design and development projects, the below workflow is being followed. We will guide you through this process, using your already implemented QMS, or our standardized QMS and related procedures and templates, for establishing/refining your product Technical Documentation.




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