Design Input: How to write requirements and modularize a product

Instructor: Richelle Helman
Product ID: 700223
Training Level: Basic to Intermediate
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2007

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

In this design Input training 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.

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

Instructor Profile:

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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Seminars by Ex-FDA Officials
Medical Device Summit 2018

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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