This webinar is intended to assist manufacturers in understanding the intent of the design controls regulations. Design controls are based upon quality assurance and engineering principles. Managers, engineers and regulatory staff must work together to make the process efficient and flawless. This webinar is conducted by the risk management consultant who turned around a Midwest company from going out of business to becoming the world leader in quality and reliability.

Topic Background:

Peace of mind for management is important to avoid worrying about device failures and recalls. Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. Instead, it establishes a framework that manufacturers must use when developing and implementing design controls. Efficient design reviews are important in mitigating risks. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes.

Course Objectives:

Engineers think like engineers and marketing people “should” think like the customer. If you are designing a product to be used by nurses then get nurses on your design team. Simple things like naming conventions, color and where the button is located are big deals – they may not cause a recall but they will impact sales. Therefore, there is an urgent need for a paradigm shift in medical device safety to enhance quality, safety, and reliability through powerful applications of human factors engineering to optimize the relationship between users and medical devices, and monitor interactions among the devices.

The marketing department must act as a guide and lead the companies to bring awareness of variations in use/misuse and device interactions with other devices. This communication is vital to improving the design controls. Marketing has to participate in design reviews much more than once. Even sales and applications/sales training people should participate in this process.

Course Outline:

• FDA requirements for design control
• Requirements for design and development planning
• Role of marketing and sales
• Role of engineering leaders
• Requirements for design input
• Requirements for design output
• Requirements for design review
• Heuristics for efficiency
• Requirements for design changes
• Requirements for design verification
• Requirements for design validation
• Requirements for design transfer
• Requirements for design history file

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Marketing Managers
• Sales Mangers
• All Senior Leaders
• All Engineering Managers
• All Hardware Design Engineers
• All Software Design Engineers
• Quality Assurance Staff
• Regulatory Staff
• Pharmacy Staff