Industrial and Medical safety certification

Industrial

Verocel’s tools enable software developers to comply with the requirements of IEC 61508 and EN 51028. From capturing all life cycle data items to test generation, coverage and module coupling, Verocel’s tools can help.

The industrial market served by Verocel includes safety-related applications such as transportation, energy and process/factory automation, among others. Each of these markets may require some form of safety certification in accordance with IEC 61508. This standard defines the objectives and activities required to ensure that electric and electronic systems can meet a pre-defined level of design assurance, thereby providing confidence that these systems are indeed considered safe.

Transportation

Transportation systems such as railways, subways and mass-transit systems generally require some form of safety certification. The standard for certification of rail systems is EN 50128 (produced by CENELEC, the European Committee for Electrotechnical Standardization). The guidance in EN 51028 is nearly identical to that of IEC 61508, with a few minor exceptions.

Energy and Process and Factory Automation

As process control systems, factories and power generation systems become more connected and automated through the use of big data and software, safety considerations and regulatory oversight are becoming paramount. These industries rely on compliance to industrial standards such as IEC 61508 for electronic systems certification. Verocel’s products and services enable customers in these industries to meet regulatory requirements.

Medical

Verocel’s tools enable medical device software developers to comply with the requirements of IEC 62304. From capturing all lifecycle data items to test generation, coverage and module coupling, Verocel’s tools can help.

Medical devices that may contribute to injury or death due to malfunction must be certified by national and/or international regulators such as the US Food and Drug Administration. Software in these safety-critical devices must be certified to meet one or more standards. IEC 62304 is the internationally-accepted standard for certification of software in medical devices. Verocel’s tools enable medical device software developers to meet these regulatory burdens.

Tools

Application Life Cycle Management Tool

Industrial – IEC 61508 and EN 50128 Part 1 – Documentation, Configuration Management, Traceability, Change Control and Independence

Medical – IEC 62304  Parts 5, 8 and 9 – Software Development, Requirements, Design, Test Cases, Traceability, Configuration Management, Problem Reporting and Change Impact Analysis

Object Coverage Analysis and MCDC Source Coverage tools

Industrial – IEC 61508 and EN 50128 Part 3 – Structural Coverage Analysis

Medical – IEC 62304 Parts 5.5 and 5.6 – Software Unit Verification and Integration Testing: Demonstrate effective structural coverage

Qualified Control Coupling and Integration Verification Tool

Industrial – IEC 61508 and EN 50128 Part 3 – Software Integration Testing: Demonstrate goodness of integration

Medical – IEC 62304 Part 5.6 – Software Integration Testing: Demonstrate goodness of integration

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