How Smaller Companies Can Use FDA's Case for Quality to Reduce Costs & Inefficiencies
Wed. February 6| 2:00 PM - 3:00 PM | 210D
Show: MD&M West 2019
Track: MD&M West: Regulatory & Quality Update
Badge Type: Paid
Medical device manufacturers can reduce costs and increase profits by focusing on quality measures during medical device design and production. This quality improvement approach pays dividends in customer satisfaction and provides significant competitive advantages. The Case for Quality program helps FDA and manufacturers reduce certain widespread or common manufacturing risks that impact product quality. In this session, experts will discuss the Case for Quality program, insights from pilot program participants for smaller companies, and how it can be used to manufacturers' advantage.
Topics covered include:
Topics covered include:
- How the program benefits practices ranging from design improvements to controlling production errors while increasing speed of detection for quality issues
- What is the process for getting involved in the program and what are the required resources?
- The Quality Program Pilot Framework and how its modifications can increase a quick review for the 30-day notice of change
- Identifying risk and mitigation strategies that are easily implemented
- Case examples demonstrating quality improvements realized through the program
