Quality Management System


Want clear cut quality policies and objectives, all while gaining customer satisfaction and meeting regulatory requirements?


Everyone’s different.

Your QMS should meet your unique product & business needs. We will help you develop all the required QMS elements!

We will build your Quality Management System to comply with the medical device regulations unique to you.

Koven is fully prepared to handle aggressive timelines to develop a complete QMS system, required to market your unique diagnostic / therapeutic product.

We are successful at meeting deadlines and delivering tailored solutions that fit your unique needs.


We can help you with:

  • Standard Operating Procedure (SOP) development
  • Quality Manual development
  • Forms and Work Instructions generation
  • Training

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