Design Input: How to write requirements and modularize a product

In this Design Input training will define design input, review robust requirements development, assess the impact of User needs Vs Patient needs and discuss options for timing your design reviews. During this seminar, we will complete a sample Design Input requirements document that you can use as a guide for writing your own requirements

Did you know that a well-planned design input phase can save you time and money in your product development process? Or that engaging your customer-facing personnel (Marketing, Sales, Customer Service) in these early stages of planning can contribute to a more successful product in the marketplace?

In this beginner/intermediate seminar, we will define design input, review robust requirements development, assess the impact of User needs vs Patient needs and discuss options for timing your design reviews.

This seminar presumes a basic understanding of the Development Planning process.

Areas Covered in the seminar:

• The FDA guidelines for design input requirements
• Identifying User requirements vs Patient needs
• Why requirements are critical to defining the device you plan to develop and sell
• What constitutes a complete requirement
• How to refine ambiguous or conflicting requirements
• Gaining buy-in from customer-focused functions (marketing, sales, customer service)
• Compliant as well as functional documentation and review
• When to refine requirements during development and when not to

Who Will Benefit:

• Quality Assurance managers and personnel
• R&D managers & engineers
• Regulatory Affairs personnel
• Quality system auditors
• Marketing product managers