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
Resource 5 Essential Traceability Components for Medical Device Development

How to Improve Medical Device Development

One of the biggest challenges in medical device development is proving compliance. Luckily, you can overcome this challenge by implementing traceability. 

Traceability in medical device testing helps you trace your requirements — for regulatory compliance — through the product lifecycle. You'll be able to tell if a requirement has cleared testing and been successfully met.

Discover the five things you need to do for traceability:

  1. Link requirements.
  2. Automate manual processes. 
  3. Get visibility. 

Simplify Compliance With Medical Device Testing

Helix ALM helps you meet medical device testing requirements and maintain compliance.


Trace Requirements

Make sure your medical devices meet compliance requirements. Trace them through the testing process. 

Reduce Risk

Reduce your risk of noncompliance with thorough and speedy medical device testing. 

Deliver Quality

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



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.

Check It Out

See for yourself how Helix ALM makes medical device testing a breeze. And see how Helix VCS makes it easy to version your devices. Sign up for our next live demo. 

Try Better Medical Device Testing

Start a free, 30-day trial of Helix ALM today. You'll see for yourself how easy it can be to prove medical device compliance and gain a competitive edge. 

Get In Touch

Have questions? We're here to help!