The Design Control Conference from Medical Device Summit will take place February 4-5, 2015, in Washington D.C. Billed as A Competitive Advantage from R&D through Postmarket, this highly interactive workshop features top industry experts and goes beyond the basic principles and processes of design control. StarFish Medical President, Scott Phillips, will participate as a member of the Design Control Faculty.
The conference focuses on the creation of a strong design control program that is well integrated into all relevant company functions and has the appreciation and support of business management.
Other Faculty members include Pat Baird, Technical Director, Baxter Healthcare, Mark Leimbeck, Program Manager, Medical Regulatory Advisory Services, UL LLC, William MacFarland, Director, Division of Manufacturing & Quality, Office of Compliance, CDRH, FDA, and Chirag Tilara, Director, Coronary Quality, Medtronic, and Thomas Maeder, Conference Director, Medical Device Summit.
Partial List of Topics:
- Design Control as a Competitive Advantage
- Internal – speed to market
- External – learning from others
- Aligning Design Control and the Business Process
- Aligning Product Development and Design Control
- Requirements gathering and management
- Design for six sigma
- Critical parameter management – verification and validation of inputs and outputs
- Overview of design control elements, principles, and best practices
- The evolving global regulatory environment and its impact
- Design Control and the Total Product Life Cycle
- Data sources
- Iterative updates and improvement
- Challenges in bridging gaps and miscommunication between teams
Monitoring and Evaluating the Design Control Process – measuring effectiveness and the impact on business