Quality
The quality of our actions is not only a reflection of ourselves but of the impact we have on the world, inspiring positive change and touching countless lives.
touching countless lives.
Quality is not only a cornerstone for our team at Resolution Medical, but it is an integral part of the healthcare ecosystem.
For good reason, the medical device industry is heavily regulated, ensuring devices meet stringent standards for safety, effectiveness, and reliability. The things we create, directly touch lives.
At Resolution Medical, our team takes quality personally, and our team of experts is at your disposal to make sure your device is safe and compliant.
Our Quality System is Collaborative and Transparent
We offer our electronic Quality Management System for your use throughout the entire development process and beyond. This system encompasses the essential facets of device history records, design history, and device master records, ensuring a holistic approach to change control, specifications, and procedures management.
Regardless of your organization’s quality system maturity, we stand ready to support you at every stage.
Real-Time Regulatory & Audit Support
Count on us for real-time audit and regulatory support during audits and approvals. We anticipate information requests and efficiently pull records during audits conducted by notified bodies.
We’ll manage your documentation, acting as the repository for your technical protocols, reports, and crucial information.
With Resolution Medical, collaborative quality assurance is more than a promise—it’s our commitment to ensuring your success.
Quality System
Contract service provider of design, development, manufacturing, assembly, testing, sterile and non-sterile packaging of medical devices and components
Compliance to 21 CFR Part 820.
Registration Number: 3012266672FEI Number*: 3012266672
Integrated web-based solutions automate and enhance quality and regulatory compliance processes by melding emerging best practices in the medical products market with collaborative technology from Microsoft.
Quality
Policy
