If Regulatory Affairs defines the external demands on your product and your company, before you are allowed to place the product on the market, Quality Assurance defines how you need to structure your operations. The Quality Management System (QMS) consists of policies, process descriptions and written procedures applicable for your Medical Device, IVD or Combination Product. Basically, it defines how you are conducting your operations. RegSmart Life Science 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.
RegSmart Life Science 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.