Medical Device Product Development Challenges

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.

2016 Life Sciences Product Development Survey Report

We surveyed product development professionals in the life science industry and uncovered valuable insights into how organizations manage product development artifacts, compliance, and traceability in the R&D phase. Here are some of the key takeaways:

  • Most life sciences companies are not able to maximize traceability to improve product quality and reduce risk.
  • Documenting work continues to consume large amounts of time, and most companies still rely on Microsoft Word and Excel.
  • The majority of respondents want to expose user needs and risk management as part of their daily development processes.

Download the full report now to learn more.

Gain Instant Traceability and Simplify Compliance 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.

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.

Trusted by Leaders in the Medical Device Industry

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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.

Check It Out

See the Helix Development Platform in action by signing up for a live demo. Hosted every other week by a Perforce Solutions Engineer, our live demos showcase the best features of Helix VCS and Helix ALM in 20 minutes or less.

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