Medical Devices Demand Regulatory Compliance

Medical device companies rely on Helix ALM to help them overcome constant challenges from competitors, government regulations, productivity and quality issues, and more.

Helix ALM delivers reduced costs, streamlined R&D processes, simplified compliance, and accelerated time to market.

Helix ALM helps medical device companies manage regulatory compliance initiatives by tracking and linking product development artifacts, verification and validation artifacts, internal validated IT systems, and other mission-critical activities — all without interrupting daily activities.

How do you handle compliance in the development lifecycle? Share your perspective in the 2018 State of Medical Device Development Survey. 

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Automatic Traceability

Simplify Compliance for Medical Device Testing with Helix ALM

Eliminate hours of manual effort required to create and maintain compliance reports.


Trace Instantly

Automate the upstream and downstream traceability of development artifacts.

Reduce Risk

Lessen your risk exposure with full audit trails, automatic notifications and escalations, and electronic signatures.

Enforce Adherence

Enforce adherence to daily development and quality assurance processes with secure automated workflows.


Improve Collaboration

Coordinate design changes across engineering teams quickly. Check on project progress and accurately forecast schedules. 

Gain Insight

Gain insight into the impact of changes with real-time data visibility, change notifications, and gap and risk analysis.

Strengthen Security

Secure file-level access to source code, work items, issues, and other product development artifacts.

From Word Docs to Compliance

How Fractyl Achieved CE Certification in Record Time

Fractyl — a clinical-stage medical technology company — was founded in 2010 with the goal to combat insulin resistance and restore metabolic health.

Twelve months ahead of schedule, they received a CE Mark for their innovative Revita™ procedure.

Ann Rossi, Senior Software Quality Assurance Manager of Fractyl Laboratories, tells Fractyl’s incredible success story — and how Helix ALM helped the company achieve compliance 12 months earlier than they expected.

Trusted by Leaders in the Medical Device Industry

Witness the Power of Perforce Helix

See how leading medical device organizations rely on Helix ALM to manage their core processes, drive innovation, and gain a competitive edge.

Resource 5 Essential Traceability Components for Medical Device Development

Essential Traceability Components for Medical Device Development

Featured Report

As you design new medical products, multiple activities, changes, and requirements must be tracked, documented, and responded to by multiple stakeholders. Learn how an automated product development solution can trace every relationship and change, and provide instant visibility into data.

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