Q & amp;A: Developing a Maturity Model Assessment for Device Makers

In an effort to push for a focus on quality over compliance, enhanced transparency, and better stakeholder engagement, FDA and the Medical Device Innovation Consortium (MDIC), a public-private partnership focused on regulatory science, created a program now in its pilot phase known as the Case for Quality program. The project paved the way for the Medical Device Discovery Appraisal Program (MDDAP), an FDA program that aims to elevate the focus of all medical device companies from baseline regulatory compliance to sustained practices that can advance medical device quality and safety to achieve better patient outcomes. The idea is to foster a new level of collaboration between the agency and the industry to create a Case for Quality movement. Mark Rutkiewicz, vice president of quality at Innovize,  one of the first companies to participate in the pilot program, has managed medical device company processes and has designed quality management systems for more than 30 years, and has written two books on the subject of implementing efficient compliance processes using virtually any tool out there. Hear Mark Rutkiewicz talk about implementing the new Medical Device Discovery Appraisal Program at the BIOMEDevice Boston conference, April 19, 2018. Use promo code "MDDI" for 20% off conference registration and free expo access. Rutkiewicz recently spoke with MD+DI about how the new MDDAP program will help companies focus on practices that can accelerate the process of bringing techn...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news