FDA 21 CFR Part 820 Compliance Solutions
Medical device manufacturers must establish quality systems and design controls to ensure their products meet applicable requirements and do not pose unacceptable risk to the consumer or public. FDA 21 CFR Part 820 is the Quality System Regulation that outlines current Good Manufacturing Practice (cGMP) requirements. Without a compliant Quality System, your device cannot be made available for commercial use.
With the unique combination of our regulatory quality support and InfoStrength’s software solution, you can create a Quality System that demonstrates how you have built safety and effectiveness into your device. From navigating the regulatory requirements to interpreting the standards, we can help you achieve FDA 21 CFR Part 820 compliance.
Meet FDA QSR Requirements
MethodSense supports 21 CFR Part 820 compliance with our proprietary pre-validated software solutions, InfoStrength Smart Enterprise Suite and InfoStrength Smart Solutions. This tool, combined with our regulatory expertise, empowers you to manage controls and collaborative capabilities for device:
- Technical files