This is a must have for anyone entering, or an expert in the 510(k) medical device industry. Portability in the form of an app is critical for medical device designers as well as physicians using medical devices and seeking new innovations for new products for unmet or under met medical needs. The app contains a developed and tested business acumen 360-IMED as a universal work plan blueprint while at the same time highlighting many critical topics of US Regulatory Affairs, intended use, materials and methods, design controls, quality systems regulation (QSR), design validation, FDA Forms and much more. Designed as a portable consultant, it is a must have.
POCKET CONSULTANT APP FEATURES:
• A proven powerful business acumen to develop & execute work plans and rethink the approach to innovation
• Tab controlled view controllers
• Easy scroll views
• Links to important FDA sites
• 21 CFR Parts 3, 4, 7, 11, 801, 803, 806 & 820
• Share capabilities
• Question & Answer section
• Portable to encourage compliance & quality of medical devices