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 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.

Try Helix ALM

Helix IPLM (formerly Methodics IPLM) is a unique IP lifecycle management platform. You can use it to collaborate on worldwide semiconductor design and establish design verification traceability for compliance with functional safety standards.

Talk to an IP Expert

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.

Try Static Analyzers

Helix Core is version control software. You can use Helix Core to securely version all digital assets — from medical device designs to embedded code. Helix Core tracks every change ever made and integrates with Helix IPLM and Helix ALM, too.

Try Helix Core

Why Use Perforce’s Medical Device Development Tools?

Perforce’s medical device development tools are best-in-class. So, you can…


Trace Requirements

Make sure your medical devices meet compliance requirements. With traceability in Helix ALM and Methodics IPLM, you can track them through the testing and design verification process.

Reduce Risk

Reduce your risk of noncompliance. Manage your SoC IP in Helix IPLM. Run your code through Helix QAC or Klocwork. And manage medical device requirements and all types of medical device testing with Helix ALM.

Deliver Quality

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



Keep developers, testers, and designers on the same page. Communicate testing requirements and automate workflows with Helix ALM, Helix Core, and Helix IPLM to keep your project running smoothly.

Gain Insight

Monitor progress and stay on top of change. Helix QAC or Klocwork give you visibility into your codebase. Helix ALM enables change impact analysis. Helix Core and Helix IPLM provide a single source of truth for hardware and software IP, source code, and digital assets.

Code Securely

Security is critical. And, Helix QAC or Klocwork 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

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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.

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