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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

FDA 21 CFR Part 820

Create a Quality System that demonstrates the safety and effectiveness of your device

IEC 60601-1 3rd Edition

Achieve easier compliance, validation, and process management

IEC 62304

Keep your SDLC activities organized and readily available

ISO 13485

Commit to the safety and quality of your medical device

ISO 14971

Identify and manage your medical device risks