regulations » 21 CFR Part 820
FDA 21 CFR Part 820 Compliance

Meet FDA QSR Requirements for Medical Device Manufacturers

Medical device manufacturers must establish quality systems and design controls to ensure that 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.

FDA 21 CFR Part 820 Compliance Solutions

InfoStrength was developed to provide the infrastructure necessary for 21 CFR Part 820 requirements. This includes controls and collaborative capabilities for device:
  • Design
  • Manufacture
  • Packaging
  • Labeling
  • Storage
  • Installation
  • Servicing
  • Technical files

With InfoStrength’s software solution and support from our regulatory experts (at MethodSense), you can create a Quality System that demonstrates how you have built safety and effectiveness into your device.

Be prepared for your next FDA inspection – contact us today.