Satisfy Quality & Regulatory Requirements
Determining this safety is often rigorous, time consuming and document heavy. MethodSense’s combination of software and consulting experience pairs to position your life science product and business operations to meet US FDA and EU regulatory affairs safety standards requirements for commercial success.
21 CFR Part 11
Manage quality, manufacturing, and business processes
IEC 62304
Keep your SDLC activities organized and readily available
FDA 21 CFR Part 820
Create a Quality System that demonstrates the safety and effectiveness of your device
ISO 13485
Commit to the safety and quality of your medical device
IEC 60601-1 3rd Edition
Achieve easier compliance, validation, and process management
ISO 14971
Identify and manage your medical device risks