QMLogic RoadMap | Documentation & Project Management Software for MedTech
Easy Software Solution for Complex Medical Projects
Finally: One Tool for the Entire Product Lifecycle Management
RoadMap is more than just a QMS or project management tool. It helps medical device organizations navigate the complex regulatory landscape of EU MDR, 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and more, while keeping all teams aligned. From concept to market release, RoadMap ensures everyone knows their role, their responsibilities, and the next steps.
“Enable regulatory compliance and project management to work hand in hand.”
QMS Collaboration Software That Brings Clarity Across Your Organization
Break down silos between R&D, Risk Management, Cybersecurity, Usability, Clinical, and Regulatory teams. With RoadMap, everyone sees who depends on whom, when documents will be ready, and how their work impacts others.
“Achieve less confusion, fewer coordination meetings, and more progress.”
Uncover Dependencies and Bottlenecks with Our Project Management Software
Track changes, plan timelines, and automatically identify risks, bottlenecks, and interconnections. RoadMap shines a light on hidden dependencies across teams and projects, so you can act before delays happen.
“Stay on schedule and save costs.”
Management Software Built on Experience, Driven by Demand
Complexity of the Product Lifecycle Management
In medical device development, the real challenge isn’t only creating the product. It is orchestrating the countless teams, documents, and processes that must move together. Engineers, regulatory specialists, and quality managers all depend on each other’s outputs, and without clarity, chaos, delays, and frustration follow.
If this sounds familiar, you’re not alone.
Even the largest organizations, with entire departments full of experts, face the very same challenges.
Built on Real-World Experience from MedTech Industry
RoadMap was built from years of hands-on industry expertise and direct requests from leading medical device manufacturers. Existing tools either focus only on quality management, design controls, or project management, leaving out the logical interconnection between these areas.
RoadMap closes this gap by connecting development, risk management, usability, clinical evaluation, and regulatory affairs — all under one roof and steered by efficient project management.
Software for Technical Documentation – Manage Design Controls with Ease
In medical device development, coordination is not only about aligning departments; it is also about aligning the technical documents they create. Various documents produced by one team often serve as a critical input for another.
Design History Files, Device Master Records, Risk Management Files, Usability Engineering Files, and many more must not only be accurate on their own, but also consistent, synchronized, and logically connected across the entire product lifecycle.
RoadMap ensures this level of coordination by making document interdependencies visible, transparent, and manageable in real time.
No More Endless Meetings with Our Project Collaboration Tool
Instead of spending hours chasing updates, RoadMap lets every professional instantly see what’s done, what’s pending, and who’s waiting on whom. Teams can focus on solving real problems instead of tedious coordination.
From Design Controls To Project Management
Software Solution for Every Level of Your Organization
For Individual Contributors – Know Exactly What to Do
Employees need to know which tasks to prioritize, whether the documents they depend on are ready, and when to expect inputs from other teams. RoadMap gives them this clarity, plus visibility into who is waiting on their documents and how urgently.
For Project Owners – Get the Full Picture
Project managers need a real-time view of where the project stands, which teams are overloaded, and whether deadlines are realistic. Instead of endless follow-ups, RoadMap visualizes all dependencies and progress, allowing managers to address bottlenecks before they become critical.
For Team Leaders – Balance Workloads with Ease
Leaders must ensure projects are distributed fairly across teams without overloading specific departments. RoadMap shows exactly where tasks and documents pile up, across which projects, and which teams may need reinforcement, all at a glance!
Integrated Management System
Where Project Management Meets QMS and Quality Assurance
Software for Bridging Management and Regulatory Worlds
Medical device development requires seamless alignment between project execution, quality management, and regulatory affairs. Without it, project managers chase deadlines and scope while missing regulatory needs, only to face delays at the finish line. At the same time, regulatory teams see the pressure on time and budget but lack ways to make their requirements visible.
RoadMap bridges this gap, ensuring speed and compliance move forward together.
Software for a True Reflection of Your QMS Processes
The RoadMap mirrors your organization’s SOPs, product lifecycle requirements, and regulatory standards. If an employee is assigned a document, they can immediately see which template to use, which process it belongs to, and at which project stage it is required.
Regulatory Compliance Without the Struggle
With RoadMap, quality and project management stop being two separate universes. Instead, they integrate seamlessly, ensuring processes are followed, documents are consistent, and everyone works in sync toward compliance and success.
End the Endless Meetings
Why Endless Reviews Exist
In the past, gathering dozens of people for hours-long review meetings seemed necessary. Without a continuous and holistic view of a project, teams had no choice but to sit together, compare documents, argue over dependencies, and guess where the real bottlenecks were. Decisions were often based on impressions, not data.
The result?
Delays, frustration, and unresolved problems.
The RoadMap Difference
RoadMap changes this completely. With a real-time, cross-project view of progress, dependencies, and responsibilities, you no longer need marathon meetings just to “catch up.” Everyone sees the current state of the project, knows who is waiting on whom, and can track issues with actual data instead of assumptions.
Continuous Transparency Instead of One-Off Catch-Ups
Instead of gathering once in a while to find out what’s wrong, RoadMap gives you ongoing clarity. Teams can act faster, resolve issues earlier, and move forward with confidence — without wasting precious hours in endless reviews.
From QMS Complexity to Project Management Clarity
The Challenge of Quality Management Systems
Every professional understands their own role and specialty. But navigating the full complexity of a Quality Management System (QMS), knowing which documents are needed, how they interconnect, and which other departments depend on them, demands an almost impossible level of system-wide expertise. Too often, people spend more time interpreting the QMS than solving the actual problems.
RoadMap Mirrors Your QMS, Without the Overhead
Our software translates the QMS into a clear, visual, and actionable workflow. It mirrors your processes one-to-one, but removes the burden of interpretation. Instead of reading through dense procedures, employees instantly see their tasks, responsibilities, and the exact place they occupy in the product lifecycle.
Focus on Work, Not on Interpreting the System
With RoadMap, employees no longer waste hours trying to understand how quality requirements connect or which documents depend on which. Everything is transparent and visualized — so teams can focus on advancing the project, not deciphering the system.
Project Management System Tool
Where Quality Meets Deadlines and Budgets
Keep Project on Track With the Right Management System
A project is never just about quality. Deadlines, costs, and team workloads are equally critical. Yet, you won’t find these elements inside a Quality Management System. And most software solutions treat these areas separately — isolating compliance from project execution.
The result?
Projects that collapse in later stages, either because regulatory needs were overlooked or because they consumed so much time and effort that the project became financially unsustainable.
QMLogic RoadMap Brings Both Worlds Together
With RoadMap, regulatory rigor and project efficiency no longer compete. Our software unites QMS requirements with project management essentials, deadlines, resources, and budgets. Instantly see not only who owns each regulatory task, but also how it impacts overall project timelines and costs.
Instant Insights, Smarter Decisions
Forget spending hours calculating schedules, workloads, and budgets. RoadMap delivers real-time dashboards that highlight project duration, bottlenecks, and resource utilization — automatically.
Employees and managers alike gain a powerful tool that ensures both regulatory compliance and on-time, on-budget delivery.
Your Powerful Product Data Management Tool
Easy Management of QMS Document and Technical Documentation
When Quality Management Systems Slow Projects Down
Every new project begins with the same struggle: figuring out which documents are required, in which sequence they must be created, and who is responsible for each of them. While all this information exists somewhere in the QMS, employees often spend hours digging through procedures, searching for templates, and piecing together instructions. Once work starts, the situation becomes even more fragmented — risk management files are hidden in one tool, usability reports in another, and templates buried in shared folders. Project managers have little visibility, teams lose time, and technical documentation becomes a source of frustration rather than clarity.
RoadMap – Your Design Control Software Tool
RoadMap changes this by centralizing control over documents and records without forcing you to abandon your existing tools. Whether you work in Confluence, Jira, DOORS, Smartsheet, or other platforms, RoadMap connects them all into one transparent system. It automatically maps responsibilities, links templates, and provides instant access to relevant SOPs and work instructions. Most importantly, it allows you to compile complete technical documentation — consistent, connected, and compliant with EU MDR and other standards — at any time. Instead of wasting hours navigating your QMS, your teams can focus on real progress, while RoadMap ensures every document is in place, connected, and ready when needed.
QMLogic RoadMap as Part of Your eQMS
QMS Is More Than Documents
A Quality Management System (QMS) is not meant to be a static collection of PDF procedures sitting on a server. At its core, a QMS is about guiding people through the right processes, setting clear standards, and ensuring overall product quality across the organization. It should be interactive, connected, and supportive, helping employees know which SOP applies, which template to use, and how their work contributes to compliance and quality.
Where Product Lifecycle Meets QMS
In medical device companies, product lifecycle activities represent 50–70% of the QMS, and consume a similar share of resources. This is exactly where RoadMap comes in. RoadMap connects all processes required for planning, design, and development, as well as all post-market activities, including product maintenance and post-market surveillance. It provides the right templates and guidance, and mirrors QMS requirements across the product lifecycle.
RoadMap – The Right Answer to QMS Digitalization
RoadMap is not “just” project management or “just” technical documentation. It brings clarity across processes, integrates guidance into daily work, and ensures that compliance is seamlessly embedded in execution. By making QMS requirements actionable and transparent, RoadMap functions as a specialized eQMS tool for product development and lifecycle management — an integral part of any modern quality management system.
More Than Software - A Partner in Your eQMS Transformation
Start with a Proven QMS Framework
With RoadMap, you don’t begin from zero. The tool comes preconfigured with a framework of the most common product life cycle documents, their inputs and outputs, and the links between them. This accelerates your QMS transformation by giving clarity from day one. You can fully adapt it, adding documents, roles, or departments, while relying on a system that already reflects best practices in regulated industries.
QMS Digital Strategy Consulting & Continuous Support
When you adopt RoadMap, you don’t just get software; you also get expert partners. Our consultants support you in shaping your QMS digital strategy, answering regulatory questions, and guiding you through design controls and compliance challenges. This continuous support ensures RoadMap works not just as a tool, but as part of your long-term QMS transformation.
QMS Integration and Automation with Your Ecosystem
RoadMap is designed to integrate with the systems you already use — from training tools and document repositories to requirements engineering and project management platforms. Our developers and solution engineers provide custom integrations and automations, making RoadMap a seamless part of your digital QMS ecosystem rather than another disconnected application.
Q&A
Q: What is a Product Lifecycle Management (PLM) system?
A: A PLM system is a software solution that helps organizations manage every stage of a product’s life — from initial idea, through design and development, to regulatory approval, manufacturing, and post-market activities. It ensures all teams work with the same information, stay aligned, and maintain compliance throughout the product lifecycle.
Q: Can QMLogic RoadMap be used as a Product Lifecycle Management (PLM) system?
A: Yes, this is exactly what RoadMap does. You can define the stages of your product’s lifecycle, assign tasks to specific roles or individuals, and track progress across all phases. RoadMap brings together design, development, risk management, cybersecurity, regulatory affairs, maintenance, and post-market surveillance, giving you full visibility and control from start to finish.
Q: What is a Product Data Management (PDM) system?
A: A PDM system is software designed to organize and control all product-related data, such as CAD files, specifications, and design documents. It ensures teams always work with the latest versions, prevents data loss, and provides a central source of truth for engineering and development activities.
Q: Can RoadMap be used as a Product Data Management (PDM) system?
A: Definitely. RoadMap was built from the ground up with a strong focus on technical documentation as an integral part of every product. Product data are managed as part of the entire lifecycle — from design inputs and outputs to software architecture, risk management files, usability reports, and regulatory affairs documents. RoadMap brings all these data sources together, providing a central source of truth for everyone working on the product, at any time.
Q: Is RoadMap an eQMS tool?
A: Yes. RoadMap is an eQMS tool that guides teams through the product lifecycle while mirroring processes exactly as defined in the Quality Management System. It visualizes these processes and puts them into motion, helping teams stay compliant with internal procedures and regulatory requirements.
Q: Can your organization help us set up an eQMS?
A: Yes. We provide comprehensive regulatory and quality management consulting services. This can include defining your regulatory and QMS strategy, identifying the right tools, and setting up RoadMap to reflect your specific needs. If required, we also help uncover gaps in your existing QMS, define or adapt processes, and support broader digitalization efforts. Whether you need only RoadMap setup or a complete QMS transformation, including integrations with tools like SharePoint, Confluence, Jira, or even AI, we deliver a tailored solution.