Kimberly Kaplan, Program Manager, Tailored Industry Solutions
Kimberly Kaplan is the current Operations Manager, Medical Device Discovery Appraisal Program at CMMI Institute. Over the past two years, Kim has been involved in the development and facilitation of the Medical Device Discovery Appraisal Program (MDDAP), also known as the “Case for Quality Voluntary Improvement Program” in the Food and Drug Administration’s (FDA’s) larger Case for Quality initiative. Through collaboration between industry and Agency stakeholders, this pilot intends to build a culture of quality across the medical device ecosystem by shifting the manufacturing focus from compliance to continuous improvement. The Capability Maturity Model Integration (CMMI) is a framework of best practices accompanied by an appraisal methodology that can help organizations both understand and increase their performance capabilities. Kim is a certified CMMI Associate and an Appraisal Team Member for the pilot program.
Conference Track: Improving Capability in the Medical Device Industry
The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has partnered with the Medical Device Innovation Consortium (MDIC), industry stakeholders, and CMMI Institute to build a pilot program aimed at shifting the industry from a mindset of compliance to one of continuous improvement. Learn how the pilot program works, key accomplishments and lessons learned, and next steps.