Stay Compliant with Medical Device Quality Support

Pre-Commercialization Quality Engineer

Compiling a Design History File (DHF) is one of the most central aspects to developing a new medical device. Our Quality Engineers, sometimes referred to as a Design Quality or Quality Assurance specialist, can assist in building quality documentation whether supporting Kapstone-driven product development projects or bolting onto your team’s development efforts. If your engineers have already worked through development of a new product, we can step in to work with them on making sure proper documentation is in place before regulatory submission or going to market.


Deliverables that Kapstone Quality typically supports for new product development include:

  • Design Control traceability
  • FMEA (design, process, application)
  • Risk Analyses
  • Supplier Qualification
  • Quality Planning
  • Verification/Validation Planning and Summary/Justification
  • Design Transfer

We’re comfortable working in quality systems other than ours, and we can quickly train on procedures to make sure we are completing documentation according to your QMS.


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