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.