Unmistakably Clear Requirements for Medical Device Projects

An ounce of prevention beats a pound of cure. Proactively analyze your PRD, SRS, and technical requirements documents for clarity, testability, and consistency.

Get Started
clock icon

Save Time

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

brain icon

Work Smarter

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

tools icon

Build Confidently

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

Accelerate Compliance

tools icon

Automate and Expedite Compliance

With the introduction of increasingly stringent Quality Management Standards such as ISO 13485, clear and testable requirements documentation has never been more important. QVscribe streamlines the authoring process of Product Requirements Documentation by individually coaching your authors as they write. By proactively helping to express each requirement clearly, QVscribe can reduce review times by 50% or more.

tools icon

Confidently Build Robust Class 2+ Medical Devices

A common understanding of the requirements lets your teams design and build with confidence. QVscribe’s standard rule set is based on the INCOSE Guide for Writing Requirements. These best practices have been proven to facilitate efficient Verification & Validation. They also 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.


Get Guide & Checklist
tools icon




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.


Get the Guide
mockup of challenges guide printout

Proactive Analysis that goes beyond the Regulatory Standards

tools icon

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 that demonstrates Quality Management System improvements over time. QVscribe generates quality analysis reports with a single click. These insightful PDF’s provide a snapshot in time that clearly demonstrates the quality at each checkpoint. It’s never been easier to prove compliance.

tools icon

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. Industry-specific terms encompass human factors, environmental considerations, sterilization, biocompatibility, cybersecurity, and much more. Using QVscribe's consistency analysis, teams can ensure that proper terms are used, prohibited terms are absent, and units of measurement are consistent with the system in use.


Handoff Requirements that are a Breeze to Verify & Validate

Today's Natural Language requirements need to be specified as complete, testable, and measurable to comply with mandated V&V processes. Correct and consistent use of imperatives such as "shall" or "must" are also required. 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. Your design and QA teams will love the results.


tools icon

Get a Free Medical Device Requirements Assessment

Your process is as unique as your team. QVscribe offers actionable insights without giving up your existing tools and preferences. We’re confident that you will see instant value in the results, so we’ve made it easy to see them for yourself. We’ll start with a simple discussion using one of our own sample documents. When you’re ready to see how your own requirements stack up, we’ll prepare a free, confidential analysis report. Ready to learn more?

Get Started

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


- Yoga Jeppu, Engineer, Honeywell Technology Solutions

money icon

Did you know?

The Project Management Institute found that 47% of unsuccessful projects failed to meet their goals due to problems with the requirements.


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