If you make medical devices, you know the only constant is change. These days, so much happens between the drawing board and the doctor’s office.

  • Tweets can redirect the market.
  • New technologies can disrupt decades of work.
  • Opportunities can come out of nowhere.
  • Regulations can change everything.

Here’s the dilemma:

You have to react fast and effectively—or fall behind. But you can’t rush it, either.

Auditors huddle outside your doors. Human lives wait in the balance. One wrong step can bring profound consequences.

So how does a modern medical device developer ship tomorrow’s breakthrough products? Not with yesterday’s ways.

You need faster collaboration. Leaner development. Smarter decision-making. Better quality than ever. And you need the tools to make it possible.

That’s why leading medical device developers pick Helix ALM for end-to-end lifecycle management.  To speed development. Without compromising quality. Without adding risk.

Here’s how it works:

  • Plan your product. Easily write requirements and build documentation. Quickly import and export word documents.
  • Develop efficiently. Create and enforce design controls. Streamline your workflow using waterfall, Agile, or hybrid methods.
  • Track progress. Dashboards deliver updates you need.
  • Test, test, test. Write, run, and automate testing at scale.
  • Manage change. See how change made anywhere affects everywhere with forward and backward impact analysis.
  • Prove compliance instantly. Generate a traceability matrix with a click. Manage approvals through electronic signatures.


Yes, the world is changing. It’s time to bring your product, process, and team into the 21st century. So you can deliver quality medical devices at the speed of change.


Helix ALM, for quality at the speed of change.

Start your free 30-day trial today.