Medical Device Quality Assurance
Quality ensures Safe, Compliant, and Dependable Devices
Quality is a mindset we apply at every stage of development. Our quality assurance team ensures your device meets global standards, and is built for safe, dependable, real-world performance.
Why It Matters
The medical device industry is highly regulated. You must prove safety, reliability, and compliance to gain approval. Our quality assurance process ensures we identfy issues early, so that we can address them and create a clear path to approval.
Our Approach
Quality and risk management are a part of every step of the process to ensure a smooth pathway to regulatory approval..
Our Quality Assurance Services Include:
Risk Management Plan Development
Risk Analysis and Risk Management Reports
Defining and Validating User Needs
Design Input and Output Documentation
Design Verification and Validation Planning
Complete Requirement Traceability Matrix
Support for Design History File (DHF) Compilation
What You Get
A thorough evaluation of your devices throughout to protect you from expensive mistakes and setbacks.