Are You Ready for an Inspection?

Quality Systems control every aspect of the design, development and manufacture of medical devices and diagnostics sold in and outside the US.  Companies wishing to sell in the US, Europe and many other parts of the world must have full quality systems that are compliant with FDA, ISO and other standards.

MDC Associates can help your company meet the required Quality System standards and get you ready for when the FDA, or another regulatory body, does come to inspect your facilities. 

MDC Quality System Services

  • Full Quality Management System development and implementation

  • QMS staff training

  • Certification support (e.g. ISO, MDSAP, etc.)

  • Internal Quality Audits (IQAs)

  • Consulting (e.g. warning letters, acquisition due diligence, vendor audits, etc.)

Why Choose MDC QS Services?

  • 20+ years of QMS implementation, certification and regulatory audit experience

  • Worked with both large and small companies and understand how to customize QMS to your needs

  • Have templates and know-how to develop effective quality system quickly

  • “We do the work” of monitoring your quality system to ensure implementation and use according to intended use

  • We have the experience, passion and practical sense of mind to guide clients through challenging projects

Connect with us to learn more!