Concept to Commercialization of Complex Medical Devices with Mobile Medical Apps

Publish Date:
October 4, 2016
Authors:
Prithul Bom, MBA, RAC, ASQ-CSQE, Senior Director, Scientific Affairs, TA Leader for Medical Device & Diagnostics and Lisa Moore, PhD, RN, Senior Director, Scientific Affairs, TA Leader for Cardiovascular

To manage chronic medical conditions, real-time monitoring of disease-specific physiologic metrics is becoming an important part of standard of care, and smartphone technology is making it possible. The challenge is that the environment in which medical monitoring systems work mandates an understanding of regulatory considerations not only for the medical device, but also the mobile medical application (MMA).

These thought leaders give an in-depth look at the device development process of MMAs that require FDA regulation and the process to market these devices. Detailed attention to steps throughout the device design and development, preclinical and clinical research phases are categorically important to achieve approval.

Download white paper here.