Meet FDA and EU Requirements

Satisfy Quality & Regulatory Requirements

Notifying bodies in the US and EU strive to ensure that medical devices are safe for patients and operators. Determining this safety is often rigorous, time consuming and document heavy. InfoStrength's combination of software and consulting services pair to position your life science product and business operations for commercial success. 

Below are just a few of the regulations InfoStrength can help you with:

21 CFR Part 11 Compliance

Confidently manage your quality, manufacturing,
business processes

FDA 21 CFR Part 820 Compliance

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

IEC 60601-1 3rd Edition Compliance

Achieve easier compliance, faster validation,
and better process management

IEC 62304 Compliance

Keep your Software Development Life Cycle
activities organized and readily available