The FDA's new Quality System (QS) Regulation (also known as the current Good Manufacturing Practices or cGMP) requires that design processes be formally planned and documented and that designs be evaluated regularly throughout the development process (section 820.30). This regulation becomes effective June 1, 1997 with the enforcement of the design control procedures starting in June 1998. This regulation applies to all manufacturers of Class II and III devices and to manufactures of selected Class I devices (in particular, those automated with computer software).
Satisfying the design requirements of the QS regulation should not be considered a burden. A GAO survey of medical device recalls between 1985 and 1989 found that 45 to 50% of all device recalls stemmed from poor product design. This study indicates the benefit that device manufactures could expect from implementing a design control program. The QS regulation should be considered an externally applied discipline that assures that designs are developed in a way that produces of an optimal or nearly optimal product. The design process will ideally result in a product that is easy to manufacture, distribute and maintain and is safe and effective in use.
I can help your company comply with the QS regulation design requirements and design better medical products. In particular, I can help you generate formal design input documents and conduct design reviews. I have both the technical and communications skills necessary to serve as a design review moderator. As a professor, I have supervised a number of design projects. Project topics have ranged from the use of neural nets for recognition of cardiac arrhythmias to an FSR based in-shoe force measurement device for rehabilitation use. My services are available directly or through our university's Applied Technology Center.