Unmistakably Clear Requirements for Medical Device Projects
Proactively analyze your product requirements for clarity, testability, and consistency.
Save Time
Streamline your analysis workflow and create detailed reports in seconds (not hours)
Work Smarter
Automate the tedious, error-prone tasks in the review and analysis of requirements
Build Confidently
Avoid costly rework later on by identifying critical errors in the requirements stage
Foster a Culture of Clear Communication
Automate and Expedite Compliance
- Increasingly stringent Quality System Regulations, such as FDA 21 CFR and ISO 13485, demand that requirements be clear, complete, and consistent.
- QVscribe streamlines the authoring process of product requirements by coaching your authors as they write.
- By proactively helping to express each requirement clearly, QVscribe can reduce review times by 50% or more.
Confidently Build Robust Medical Devices
- A common understanding of the requirements lets your teams design and build with confidence.
- QVscribe's analysis is based on best practices that facilitate efficient and effective Verification & Validation.
- These help to avoid inconsistencies and ambiguities that lead to rework, engineering confusion, scope creep, and costly product recalls.
Resources
Medical Device Guide & Checklist: The 10 Essentials for Writing a Clear Product Requirements Document
We distilled the insights from our research into this one guide + checklist that we hope will help accelerate the requirements engineering phase of your medical device projects.
How to Overcome the Top 4 Challenges in Medical Device Manufacturing
Covering the top 4 challenges faced by the medical device manufacturing industry, this article explains how effective requirements planning allows organizations to proactively position themselves to meet unique challenges associated with medical device manufacturing.
Reduce Friction in your Development Process
Generate Quality Reports Instantly with One Click
These insightful PDF’s provide a snapshot in time that clearly demonstrates the quality at each checkpoint. These reports are useful in situations such as:
- Providing a progress report to management
- Preparing for a design review meeting
- Reviewing the results of the analysis with other stakeholders
Enforce Consistency with Customizable Configurations
It’s difficult to keep teams on the same page with ever-changing rules regarding acceptable terminology. QVscribe’s consistency analysis and customizable configurations help to ensure that:
- Proper terms are used
- Prohibited terms are absent
- Units of measurement are consistent with the system in use
Handoff Requirements that are a Breeze to Verify & Validate
- Today's medical device requirements need to be specified as complete, testable, and measurable to comply with mandated V&V processes.
- QVscribe's quality analysis ensures that each requirement includes one and only one clear and verifiable statement.
- When Testing and Quality Control receive these requirements, there will be a common understanding of how to test that each requirement has been met.
Let's Talk
QVscribe offers actionable insights and works with your existing tools. We’re confident that you will see instant value in the results. Schedule a call today and learn how other medical device teams are using QVscribe to accelerate their product development.
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