Requirements Analysis for Medical Device Projects

An ounce of prevention beats a pound of cure – proactively analyze medical device for clarity, testability, and consistency throughout the Product Requirements Documents (PRD) authoring process.

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Save Time

Streamline your analysis workflow and create detailed reports in seconds (not hours)

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Work Smarter

Automate the tedious, error-prone tasks in the review and analysis of requirements

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Build Confidently

Avoid costly rework later by identifying critical errors in the requirements stage

Accelerate Compliance

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Automate and Expedite Compliance

With the introduction of increasingly stringent Quality Management Standards such as ISO 13485, the necessity demanded for clear and testable requirements documentation has never been more critical. QVscribe streamlines the authoring process of Product Requirements Documentation by automatically checking each requirement has met today's quality standards – proactively ensuring each requirement is authored correctly & saving over 50% on requirements development time.

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Confidently Build Robust Class 2+ Medical Devices

Using QVscribe enables medical device teams to build confidently with Product Requirements Documents that have been analyzed to satisfy today's best practices and standards. These are best practices that are proven to facilitate efficient Verification & Validation while avoiding inconsistencies and ambiguities that lead to rework, engineering confusion, scope creep, and costly product recalls.


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.

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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.

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Proactive Analysis that goes beyond the Regulatory Standards

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One-Click Report Generation for your Quality Management System Paper Trail

Regulations for Class 2+ medical devices are placing increasing importance on possessing a valid paper trail demonstrating Quality Management System improvements over time. QVscribe's one-click quality reports enable analysts to quickly generate full quality analysis reports – holding your integration of software and hardware accountable to the standards necessary for compliance.

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Enforce Consistency Across the Team with Terminology & Unit Constraints

Today's medical device teams need to consider terminology from many different stakeholders, suppliers, and standards that encompass human factors, environmental considerations, sterilization, biocompatibility, cybersecurity, and much more. Using QVscribe's consistency analysis, teams can ensure that correct terms are used, prohibited terms are absent, and units of measurements are consistent with the system in use.

Handoff Requirements that are a Breeze to Verify & Validate

Medical device Product Requirements Documents are written in Natural Spoken Language. However, formalized verification and validation required by today's standards mandate that today's Natural Language requirements be specified as complete testable and measurable requirements with the correct and consistent use of imperatives such as "shall" or "must". QVscribe's quality analysis immediately flags requirements with invalid use of imperatives, while also checking for phrasing that renders a requirement untestable and/or impossible to measure.

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Get a Free Medical Device Requirements Assessment

We're excited to show you how QVscribe can dramatically save you significant time achieving compliance and building today's robust medical devices. Schedule a time with one of our requirements specialists to discover how much compliance and development time you could be saving. Your requirements specialist will customize a session around your chosen product requirements document that assesses risk, quality standards violations, and much more.

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QVscribe is a lightweight pragmatic solution that can drive requirements document quality improvement.

- Yoga Jeppu, Engineer, Honeywell Technology Solutions

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Did you know?

The Project Management Institute’s 2014 Pulse of the Profession found that only 47% of organizations have a formal process to validate requirements. And that 51% of At a Glance Requirement Analysis project dollars are wasted due to poor requirements.

PMI - Pulse of the Profession, Project Management Institute, 2014


QVscribe is seamlessly integrated into the following requirements management tools.

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Microsoft Excel

Quality analysis integrated right into your current Excel workflow.

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Microsoft Word

Quality analysis integrated right into your current Word workflow.

Rethink Requirements Today

Put QVscribe to the test on your documents to see how much time and rework you could be saving.

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