Why Medical Device Lifecycle Management Is Important

There are endless challenges in the medical device industry. 

You need to:

  • Innovate to keep up with competitors.
  • Meet ever-changing government regulations.
  • Increase productivity across teams.
  • Improve medical device quality.

Beating any of these challenges is hard. Beating them all is impossible.

Unless you have the right medical device lifecycle management solution to: 

  • Gain a competitive edge.
  • Meet compliance every time.
  • Automate manual processes.
  • Test medical devices faster.
Automatic Traceability
2018 State of Medical Device Development Survey Results

What's the State of Medical Device Development?

In this year’s “State of Medical Device Development” survey, nearly 200 medical device developers shared how they handle everything from managing requirements to going Agile to proving compliance.

Find out what they said about:

  • Trends in medical device development.
  • Challenges in medical device development.
  • The future of medical device development.

Simplify Medical Device Compliance

QAC/QAC++ and Helix ALM Make It Easy

benefits-traceability

Trace Requirements

Make sure your medical devices meet compliance requirements. With traceability, you can track them through the testing process. 

Reduce Risk

Reduce your risk of noncompliance. Run your code through static code analyzers. And do thorough and speedy medical device testing with Helix ALM. 

Deliver Quality

Produce the best possible medical devices faster. Perforce makes QA a breeze. 

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Collaborate

Keep developers and testers on the same page. Communicate testing requirements and automate workflows to keep your project running smoothly. 

Gain Insight

What will happen if your regulatory compliance requirements change? With Helix ALM, you'll be able to do an impact analysis and stay on top of requirements change. 

Strengthen Security

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

How Will Helix ALM Help You?

See for yourself why leading medical device manufacturers rely on Helix ALM. Sign up for our next live demo. You'll learn how Helix ALM will help you manage your core processes, drive innovation, and gain a competitive edge.

Trusted by Leaders in the Medical Device Industry

 

From Word Docs to Medical Device Compliance

How Fractyl Achieved CE Certification in Record Time

Fractyl — a clinical-stage medical technology company — used to manage requirements in Microsoft Word documents. That made it hard to comply with regulations. 

But when they implemented Helix ALM, they received a CE Mark for their innovative Revita™ procedure — twelve months ahead of schedule. 

Watch this webinar to hear from Ann Rossi, Senior Software Quality Assurance Manager of Fractyl Laboratories. 

You'll learn: 

  • What they needed from medical device testing.
  • Why Word docs and Jira issues weren't enough.
  • How Helix ALM made medical device compliance easy.

Medical Device Testing

See for yourself how Helix ALM makes medical device testing a breeze. Sign up for our next live demo. 

Coding Standards

Complying with coding standards helps you produce better medical devices. See how QAC/QAC++ can help. 

Get In Touch

Have questions? We're here to help!