Embedded Software in the Medical Device Industry
In the fast-evolving healthcare industry, medical device software plays a vital role in device functionality and patient safety. As devices grow more complex, ensuring high-quality software is essential to avoid software failures, which can delay regulatory approvals, harm brand reputation, and, most critically, endanger lives.
To address these risks, the industry increasingly relies on international standards like IEC 62304. This standard defines the life cycle requirements for medical software and emphasizes the need to follow coding guidelines like MISRA and CERT to improve software reliability and security.
Adhering to IEC 62304 helps manufacturers deliver safer, more reliable devices, ensuring regulatory compliance and protecting patient safety.
Key Standards for Medical Device Software Quality
The IEC 62304 standard is essential for managing software in medical devices, ensuring regulatory compliance, mitigating risks, and achieving global acceptance. MISRA C/C++ coding standards enhance software safety, reliability, and maintainability, while CERT C/C++ standards focus on secure coding, reducing vulnerabilities and improving patient safety.
These standards are critical for guaranteeing software quality, safety, and security in the medical device industry, benefiting both patients and manufacturers by meeting stringent regulatory requirements.
IEC 62304
Medical device software – software life cycle processes
MISRA C/C++
Guidelines for the use of the C/C++ languages in critical systems
CERT C/C++
Secure Coding Standard
QA Systems Testing Tools
QA Systems enables organisations to accelerate safety standards compliance with automated static analysis and software testing tools:
STATIC ANALYSIS
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