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:

FDA 21 CFR Part 11 & Annex 11 Confidently manage your quality, manufacturing, 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 A1 Achieve easier compliance, faster validation, and better process management
IEC 62304 Keep your Software Development Life Cycle activities organized and readily available