Requirements

We'll provide your requirements engineering and maintenance capabilities, or build them into your organization.


Requirements Engineering - we'll analyze your product concept and target market, and develop requirements for you at any of the following levels:

⇒ Product roadmap

⇒ Customer Needs

⇒ Product Requirements

⇒ Functional Requirements for software, hardware, and reagents


Requirements Management - we'll set up systems and procedures for your project, or your entire organization, to manage the development and maintenance of requirements.

Your company will be able to protect time-to-market and save money by :

⇒ Using lifecycle processes that capture the value of Agile techniques while remaining FDA-compliant

⇒ Concurrently embedding traceability into requirements, designs, and tests, and benefit from the power of trace.

⇒ Creating meaningful tests and reviews  that prepare your team and your product for launch and on-market support.

♦ Don't let defects escape into your installed base

♦ Find problems as they occur; don't wait until systems integration or clinical evaluation

⇒ Eliminating wasted iterations for troubleshooting and re-design

⇒ Preventing field actions and CAPAs for on-market product revisions

⇒ Illuminating Critical Systems Quality Attributes to support your product's value proposition in the field, such as

♦ Reliability

♦ Testability

♦ Manufacturability

♦ Supportability

♦ Maintainability

⇒ Discovering Critical Quality Attributes and write part specifications that retain their true constraints

♦ Never lose track of why a specific part was selected, even during sustaining engineering to handle supplier part obsolescence



 Do all of this while avoiding the bureaucracy monster. Let us show you how.