Design Input: How to write requirements and modularize a product

Speaker

Instructor: Richelle Helman
Product ID: 700223
Training Level: Basic to Intermediate

Location
  • Duration: 60 Min
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.
RECORDED TRAINING
Last Recorded Date: Mar-2007

 

$99.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$199.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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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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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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