Quality Systems Management

Need to prepare for regulatory submission and market release?


Get a proven QMS and an experienced quality manager. Our Quality Systems Implementation & Management (QSIM) service provides an instant quality function to establish and maintain regulatory compliance.

How does it work? We create a dedicated electronic repository to house your quality system and records. Then we port over our SOPs and templates to make them yours.

What's included? We handle the back-end operations of quality systems management.

  • Training
  • Auditing
  • Electronic Signature Routing (21 CFR Part 11 Compliant)
  • Document Control
  • Other needs



Committed to assisting clients with the development of safe and effective medical devices.

Our commitment to excellence is reflected in a robust Quality Management System (QMS) compliant with 21 CFR 820 FDA Quality System Regulation and ISO 13485:2016.


Want to explore QSIM

Let's discuss if QSIM is the right fit for your company's quality system needs.