Medical Devices

Industry Standards

IEC 61508

Model-Based Design is used for developing embedded software in the automotive, industrial automation and machinery, and other industries and application areas. Engineers use Model-Based Design to produce software that complies with the IEC 61508 functional safety standard. These applications need extra consideration to address the constraints imposed by the standard and to produce the required evidence to demonstrate compliance.

IEC 61508 was developed for the industrial automation industry, but derivatives for other industries such as rail (EN 50128), medical (IEC 62304), and machinery (IEC 62061) exist. In automotive, the draft international standard ISO 26262 is becoming relevant for the passenger cars segment. IEC 61508 is still used for commercial vehicles—especially off-highway vehicles.

IEC Certification Kit aids certification for IEC 61508 and its derivative standards including ISO 26262. It supports Embedded Coder and Polyspace code verification products.

More about MathWorks support for IEC 61508:

IEC 62304

IEC 62304 specifies the requirements of the software life-cycle processes used in the development of medical device software. It has been harmonized by the EU and U.S. and can be used to comply with regulatory requirements within these regions as it pertains to medical device software. This standard provides requirements for each life-cycle process, which is further divided into a set of activities and tasks.

IEC 62304 does not specify functional safety; it is typically used in conjunction with IEC 61508, which is a functional safety standard. Also, the IEC 62304 standard encourages readers to use IEC 61508 as a source for good software methods, techniques, and tools (stated in section C.7). Engineers use Model-Based Design to produce software that complies with IEC 62304 and IEC 61508.

IEC Certification Kit aids certification for IEC 61508 by providing examples to support tool qualification efforts. It supports Simulink Verification and Validation, Embedded Coder, and Polyspace code verification products.

More about MathWorks support for IEC 62304: