Challenges in Medical Device Development

There are endless challenges in the medical device industry.

The quality of software embedded in medical devices can mean the difference between life and death. And there is increasing scrutiny for both safety and security in devices.

So, 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 testing and development tools to:

  • Gain a competitive edge.
  • Meet compliance every time.
  • Automate manual processes.
  • Test medical devices faster.
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What's the State of Medical Device Development?

In our “State of Medical Device Development” surveys, hundreds of 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.

Important Standards in Medical Device Manufacturing

There are several important standards for compliance in medical device manufacturing.

IEC 62304

IEC 62304 specifies lifecycle requirements for medical devices and medical device software.

ISO 14971

ISO 14971 is the risk management standard for medical devices.

ISO 13485

ISO 13485 specifies the quality management requirements for medical devices.

FDA Regulations

Several FDA regulations are also applicable to medical devices, including 21 CFR Part 11.

European Medical Device Directives

European Medical Device Directives are required for selling medical devices in the European Union. Compliant devices receive a CE Mark.

Medical Device Testing and Development Tools

Medical device developers count on Perforce tools for compliance.

Helix ALM for Testing & Traceability

Helix ALM is an end-to-end ALM tool with modules for managing requirements, tests, and issues. You can use it to make sure every requirement is tested and fulfilled. And you can use it to create a traceability matrix for FDA and ISO compliance.

Helix Core for Version Control & Collaboration

Helix Core is version control software. You can use Helix Core to securely version all digital assets — from medical device designs to embedded code. And because Helix Core tracks every change ever made, you have full traceability for compliance.

Static Code Analysis for Code Quality & Compliance

Klocwork and Helix QAC are static code analyzers. You can run either over your code and find defects earlier in development — when they’re easier (and less expensive) to fix. Static analyzers help you to comply with C and C++ coding standards that are essential to medical device development.

Why Use Perforce’s Medical Device Development Tools?

Perforce’s medical device development tools — Helix ALM, Klocwork, and Helix QAC — are best-in-class. So, you can…


Trace Requirements

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

Reduce Risk

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

Deliver Quality

Quality is a must-have for medical devices. Using Klocwork and Helix ALM assures you deliver the highest-quality devices.



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

Gain Insight

Monitor progress and stay on top of change. By using Helix QAC or Klocwork, you'll be able to effectively monitor your code base to stay on top of necessary changes. And, with Helix ALM, you'll be able to do an impact analysis and stay on top of requirements change.

Code Securely

Security is critical. And, Helix QAC keeps your code secure. You can automatically apply coding rules (from MISRA or other standards) and ensure your code is error-free.

Trusted by Leaders in the Medical Device Industry

Image Solution Med Device SGS TUV

Certified for Medical Device Compliance Standards

SGS TÜV SAAR has independently certified Helix QAC as usable in the development of safety-critical software according to ISO/IEC 62304 up to safety class C.

Medical Device Testing

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

FDA Compliant

Ensuring that your medical device software is compliant with FDA standards is essential. See how Perforce's static code analyzers — Klocwork and Helix QAC — can help. 

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