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.
Important Standards in Medical Device Manufacturing
There are several important standards for compliance in medical device manufacturing.
IEC 62304 specifies lifecycle requirements for medical devices and medical device software.
ISO 14971 is the risk management standard for medical devices.
ISO 13485 specifies the quality management requirements for medical devices.
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 helped us go from Word docs to compliance and CE certification in record time.
“We chose Helix ALM because it provided excellent performance for the price. We particularly value features such as the ease by which documents can be synchronized, the ability to share work items across documents, and simple interfaces for customers.”
Helix ALM is very cool. It’s the best software investment I’ve made in a long time.
"With Helix QAC our prototypes retain much of their integrity, because most defects are caught early. Even as our goals evolve and the code changes, our product quality remains consistently high."
Trusted by Leaders in the Medical Device Industry
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.
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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