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.
Simplify Compliance for Medical Device Testing with Helix ALM
Eliminate hours of manual effort required to create and maintain compliance reports.
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
Essential Traceability Components for Medical Device Development
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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