Design Input: How to write requirements and modularize a product

Instructor: Michelle Sullivan
Product ID: 700517
Training Level: Basic
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2007

Training CD / USB Drive

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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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

Instructor Profile:

Michelle Sullivan,, is a consultant with AlvaMed, LLC, an innovative medical technology consulting firm. She is a key contributor to AlvaMed’s Business Development and Product Development & Project Management practice, having over 14 years of experience in the medical device industry.
Michelle has developed and launched a variety of products and has managed multi-million dollar product lines to deliver exceptional product line growth year-to-year. She has experience in both product management and R&D, leveraging both disciplines to translate customer needs into actionable engineering requirements.
Her diverse career has provided her with experience in all phases of a design (from concept through commercialization) from engineering, project management and marketing viewpoints in the areas of vascular implants, catheter-based delivery systems, cosmetic surgery and in-vitro diagnostics.

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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.

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