Reducing The Documentation Burden In FDA Design Control Process By Using A Web-Based System

By Matthew M. Lowe, Master Control Systems

Introduction

The design and development of medical devices is a challenging endeavor in and of itself. Add to that the regulatory environment in which medical device developers must operate, and the task can seem insurmountable.

Since 1996, the FDA has required manufacturers of some Class I and all Class II and III medical devices to follow Design Control principles per Subpart C of the Quality System Regulation (QSR). The mandate added a whole new level of complexity to the already demanding medical device development process. In addition to the design and testing of devices, development engineers must now focus on ensuring that all of the necessary documentation is in place to demonstrate compliance with Design Controls. This documentation can amount to several hundred pages or more for a single product launch.

Only those companies able to deliver high quality, innovative products in the shortest amount of time possible while maintaining regulatory compliance will survive in today's fiercely competitive market. Accelerating any part of the development process promises to bring significant returns in this environment where speed-to-market is critical. This white paper will explore ways of reducing the documentation burden and accelerating overall project timelines by taking advantage of the technology offered by Web-based document management systems.