The FDA Design Control Guidance for Medical Device Manufactures states that “Development of a solid foundation of requirements is the single most important design control activity.”
Having good requirements is important for regulatory compliance. However, good requirements are essential for successful product development. Requirements are the foundation of your product development process.
Would you build your house on quicksand? Don’t base your product development on a weak set of requirements.
We can provide integrated services to ensure that you get requirements right –
Training on Requirements Development / Management, so that your team con learn and follow best practices when developing and managing requirements
Generation of a Requirements Management Plan to define requirements hierarchy, requirements attributes to be used, traceability requirements and additional information to document how requirements will be managed
Facilitator lead sessions for rapid development of Customer Requirements, System Requirements and Use Cases.
Improve existing requirements through expert review and updates.
Review or generate verification and/or validation protocols to ensure appropriate coverage