Bring Quality Medical Devices to Market Faster

Why Disconnected Systems Stall Compliance & Market Launch

Medical device development demands more than engineering excellence — it requires precision, traceability, and regulatory compliance. While spreadsheets and disconnected systems may work initially, they become liabilities as your products, team, and compliance needs grow. Fragmented tools and manual processes create friction at every turn:

Unclear requirements and a lack of change management process slow teams down and invite costly mistakes.
No governed workflow means inconsistent execution and missed steps.
Gaps in auditability and compliance make audits high-stress and high-risk.
Lack of proper test management/coverage undermines product quality and slows validation.
Limited traceability, visibility, and insights keep you in the dark until it’s too late.

To move faster and achieve compliance, you need the right infrastructure.

image-why-medical-professinals-choose-alm@2x.png

Why Top Med Device Teams Choose Application Lifecycle Management (ALM)

End-to-end traceability fundamentally transforms how medical device teams operate. An ALM solution connects all development artifacts, documenting every change from initial request to final approval. This gives stakeholders, managers, and regulators instant access to both high-level overviews and detailed information throughout the product development lifecycle.

An integrated solution like Perforce ALM (formerly Helix ALM) enables:

Clear visibility into every action, change, and decision
Faster, more informed decision-making through accurate, real-time data
Streamlined collaboration, reducing errors and improving efficiency
Continuous compliance, tracking every step of verification, validation, and product approval

With the right solution, you will move faster, reduce waste, and bring high-quality products to market with confidence.

Watch Perforce ALM in Action

See how ALM delivers end-to-end traceability — enabling better oversight, faster approvals, and greater control over your medical device development lifecycle. The result? Faster time-to-market without compromising product quality.

Take Control of Your Entire Product Lifecycle with Perforce ALM

Perforce ALM is built to help medical device teams overcome complexity and deliver safer products faster by bringing your team, data, and process into one platform. With dedicated modules for requirements, test cases, and issue management, ALM offers a comprehensive solution that delivers unparalleled traceability.

These key capabilities of ALM make it a must-have tool for medical device teams:

Requirements Management

Easily create, share, and review requirements while reusing them across projects.

Testing Management

Create test cases linked to requirements and ensure thorough testing before release.

Issue Tracking

Automatically track and resolve issues generated from failed test runs.

Traceability Matrix

Generate traceability matrices effortlessly to prove compliance.

Automated Workflows

Streamline development with automated workflows handling events, transitions, and rules.

Risk Management

Manage risk through requirements, risk analysis, and traceability to ensure compliance.

Metrics & Reports

Make data-driven decisions with reports on progress, impact, and productivity.

Endless Integrations

Integrate seamlessly with existing tools like Jira, Jenkins, and Slack, or any other tool via REST API.

How Perforce ALM Transformed Leading Medical Device Manufacturers

[{"title":"Fractyl Laboratories","description":"Fractyl Laboratories cut approval timelines and eliminated manual document tracking by adopting Perforce ALM. Moving from Word docs to a centralized, traceable system gave their team total visibility across requirements, testing, and risk. The team was able to improve oversight, speed up approvals, and achieve CE certification ahead of schedule.","cta_link":{"text":"Learn More","url":"entity:node\/2490"},"customer_review":{"quote":"\u003Ch4\u003E\u201cHelix ALM [now Perforce ALM] helped us go from\u0026nbsp;Word docs to compliance and CE certification in record time.\u201d\u0026nbsp;\u003C\/h4\u003E","reviewer":{"name":"Ann Rossi ","title":"","company":"Senior Software Quality Assurance Manager | Fractyl Laboratories","image":null}},"use_case_details":[{"title":"Record Times for CE Mark in Medical Device and More","content":"\u003Cp\u003EPerforce ALM helped Fractyl achieve several compliance certifications in record time, including:\u003C\/p\u003E\u003Cul\u003E\u003Cli\u003EISO 13485 (2003 version)\u003C\/li\u003E\u003Cli\u003ECE Mark \u2014 12 months ahead of schedule\u003C\/li\u003E\u003Cli\u003EISO 13485 (2016 version)\u003C\/li\u003E\u003C\/ul\u003E\u003Cp\u003EAchieving compliance is important to ensure patient safety. Fractyl can be confident that the Revita\u2122 DMR System is thoroughly tested to determine procedural safety for patients.\u003Cbr\u003E\u0026nbsp;\u003C\/p\u003E\u003Cp\u003E\u003Cimg src=\u0022\/sites\/default\/files\/inline-images\/Fractyl-Health%404x_1.png\u0022 data-entity-uuid=\u0022b700fa6c-c214-40ec-8093-4c1ff288dc5a\u0022 data-entity-type=\u0022file\u0022 width=\u0022231\u0022 height=\u002265\u0022\u003E\u003C\/p\u003E"}]},{"title":"Vyaire Medical","description":"Vyaire Medical transformed their product development workflow by migrating from legacy systems to Perforce ALM. The team now enjoys seamless traceability and easy access to both new and historical data, making it simpler to maintain compliance and improve project efficiency. They can quickly track all aspects of development, streamlining audits and ensuring timely product delivery.","cta_link":{"text":"Learn How","url":"entity:node\/3049"},"customer_review":{"quote":"\u003Ch4\u003E\u201cThe whole process of bringing everything from our old database into Helix ALM [now Perforce ALM] went so smoothly. And we can still create a traceability matrix that references the old data if we need to. That, for me, is the biggest benefit.\u201d\u003C\/h4\u003E","reviewer":{"name":"Thomas Markert","title":"","company":"Research and Development Verification Team Manager | Vyaire Medical","image":null}},"use_case_details":[{"title":"ALM Offers Unparalleled, End-to-End Traceability","content":"\u003Cp\u003EAccording to the team, ALM offered more thorough traceability than their previous solution through key features:\u003C\/p\u003E\u003Cul\u003E\u003Cli\u003EMore ways to link requirements, test cases, and other items to show the relationships and dependencies between various development artifacts.\u003C\/li\u003E\u003Cli\u003EAutomatic traceability matrix generation, resulting in an immutable single source of truth.\u003C\/li\u003E\u003Cli\u003EBuilt-in traceability reports to compare historical data with baselines.\u003C\/li\u003E\u003C\/ul\u003E\u003Cp\u003E\u003Cbr\u003E\u003Cimg data-entity-uuid=\u0022ccfca0a9-132d-4e77-a955-e2755a35c7c4\u0022 data-entity-type=\u0022file\u0022 src=\u0022\/sites\/default\/files\/inline-images\/Vyaire-Logo%404x.png\u0022 height=\u002251\u0022 width=\u0022231\u0022\u003E\u003C\/p\u003E"}]}]

Ready to Take Control of Your Product Development Process?

See how Perforce ALM can help your team reduce risk, accelerate development, and improve compliance outcomes. Get pricing information or a custom demo.