Quality Management System Integration

Quality Management System Integration

The dynamic nature of the orthopedic industry has recently lead to a high number of  acquisitions, and often times these acquisitions include manufacturing facilities with independent Quality Systems. 

When a manufacturing facility accompanies an acquisition, the integration of the Quality Management System (QMS) is often a looming task for acquiring companies. This is where Resolve Surgical Technologies can help.

Our QMS integration team has completed a wide variety of post-acquisition projects for large Original Equipment Manufacturers (OEMs). We are experienced in working within OEM quality systems, or translating quality documentation into Resolve’s European Union Medical Device Registration (EUMDR) Compliant QMS, resulting in Resolve offering a competitive manufacturing partner experience. Learn more about how we can help your organization overcome the hurdles of QMS Integration with tailored options.

Services available for QMS Integration

  • Transfer documentation to EUMDR Complaint Quality System
  • Assimilation of Design History File (DHF) Documentation
  • Gap Assessment
  • Translating Document Structure
  • Design Transfer

Bridging the Integration Gap

Our CDMO+ market model is designed to facilitate a seamless transition into fully integrated QMS systems, eliminating the typical resource and time constraints experienced by OEMs. Resolve’s quality system integration services are not just solutions but strategic advantages for your business.

Collaborate With us

We are always looking for new opportunities to collaborate and innovate with external partners to help improve patient lives. If your company is looking for a partner to accelerate innovation and speed to revenue, please fill out the following form. Do not submit confidential or proprietary information through this form.