Design Input: How to write requirements and modularize a product
Instructor:
Richelle Helman
Product ID: 700223
Training Level: Basic to Intermediate
- Duration: 60 Min
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 provide 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.
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
Richelle Helman, is a senior consultant with AlvaMed, LLC, an innovative medical technology consulting firm. She is a key contributor to AlvaMed’s QA/RA and Design Control practice, having over 19 years of experience in the medical device industry.
Richelle has driven the implementation of an improved design control system in response to an FDA 483 within the project team and has developed and implemented other design control systems. Her diverse career has provided her with experience in all phases of a design (from concept through commercialization) from engineering, quality assurance, regulatory affairs and project management viewpoints in the areas of cardiology, urology, ophthalmology and artificial organs.
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