Express Logic Announces Safety-Critical Certification Pack for ThreadX RTOS for RTCA DO-178B and FDA 510(k)

ThreadX has proven itself in over 750 million electronic devices, many of which are required to meet stringent aviation, medical, industrial, transportation, and rail safety and reliability standards. To date, ThreadX customers have performed the tests and validations themselves and produced all required documentation. By introducing a turnkey Certification Pack for ThreadX, Express Logic now can help embedded device manufacturers eliminate many developer-months of verification and validation effort in complying with rigorous reliability and safety-critical regulatory standards.
FDA Introduces New Stringency for Medical Devices.

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is responsible for new medical devices brought to market in the US, and for the recall and examination of existing devices suspected of malfunction. Devices are classified as Class I, II, or III according to their potential for injury. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify FDA of their intent to market a Class II medical device at least 90 days in advance. This is known as Pre-Market Notification and it allows FDA to determine whether the device is substantially equivalent to a device already in the market. Class III devices, posing a greater risk than Class II devices, require Pre-Market Approval (PMA), a more rigorous and lengthy process, requiring documentation akin to that required by IEC-61508 and DO-178B. Class I devices are deemed not to pose significant risk and do not require Pre-Market Notification or approval.

On July 31, 2008 a Senate Bill cosponsored by Senators Edward Kennedy (D – MA) and Chuck Grassley (R – IA) was filed that would require senior officers or directors of drug and medical device companies to certify under penalty of perjury that all information submitted for a product’s approval is accurate and in compliance with federal regulations. The Bill provided that product applications later found to have contained false or misleading information would be subject to stiff fines (up to $5,000,000), assessed both to companies and their senior officers, who, in addition, could face jail sentences of up to 20 years.

“As the US and International governments raise the stakes for company CEOs to make sure their products operate safely, it is incumbent on them to use best practices in the design and development of those products,” noted Dr. Jerry Krasner, a former medical device company CEO and current chief analyst for Embedded Market Forecasters. “Express Logic’s Certification Pack can help medical companies be confident that the RTOS used in their devices will satisfy FDA scrutiny and will help them defend against any product liability claims they may encounter down the road.”

Aviation Systems Are Regulated by the FAA
DO-178B, Software Considerations in Airborne Systems and Equipment Certification, is a document published by RTCA. When specified by the Technical Standard Order (TSO) for which certification is sought, the FAA applies DO-178B as the document it uses for guidance to determine if the software will perform safely and reliably in an airborne environment. Certification generally is required for all software that is used in aviation within the USA, and as part of the Gobal Air Traffic Management (GATM) for International operations. DO-178B defines five levels of criticality, with increasing degress of certification demands, based on the consequences of a failure.

“Since the RTOS controls the target system and applications, the RTOS must have certification evidence to the same software level as the system being supported, and demonstrate a level of confidence in the determinism of the RTOS and the control of the applications,” commented Steve Balacco, Director of the Embedded Software and tools Practice, VDC Research Group. “For avionics systems that require a small, fast RTOS, Express Logic’s ThreadX is now capable of meeting these requirements as a commercial-off-the-shelf solution.”

Industrial Systems and IEC-61508
The International Electrotechnical Commission (IEC) is a worldwide organization for standardization in the electrical and electronic fields. IEC 61508, the international standard for electrical, electronic and programmable electronic safety related systems, sets out the requirements for ensuring that systems are designed, implemented, operated and maintained to provide the required safety integrity level (SIL). Similar IEC standards relevant to other industries include:
• IEC 61511 Process industries
• IEC 61513 Nuclear power plants
• IEC 62061 Machinery sector
• IEC 61800-5-2 Power drive systems

Today, the ability to deliver a quality product before a competitor frequently determines ultimate market share and profitability. To keep projects on schedule, it’s beneficial to consider reducing project scope, while still achieving the same goals. By using a reliable, field-proven COTS RTOS such as ThreadX, along with a Safety-Critical Certification Pack, developers can eliminate many developer years from their project schedule and increase the likelihood of successful, on-time completion. The ThreadX Safety-Critical Certification Pack addresses the requirements of many safety certification standards, and is a 100% turnkey solution for certification of the RTOS used in a safety-critical system.

ThreadX Certification Pack
The ThreadX Certification Pack is a turnkey solution for meeting the RTOS-related aspects of standards for safety-critical systems. The ThreadX Certification Pack includes all source code, documentation, coverage analysis, validation artifacts, and summary report for submission to the governing agency as part of the overall system certification. Each Pack is pre-tailored for the specific standard addressed (e.g., DO-178B, Level A), the Operating System used (i.e., ThreadX), and the Target Environment (i.e., processor, board, development tools, etc.), leaving nothing for the customer to do, but submit the evidence to the certifying authority.

A typical ThreadX Certification Pack contains the following:
• Software Safety Requirements
• Software Safety Validation Plan
• Development Plan
• Configuration Management Plan
• Quality Assurance Plan
• Verification/Test Plan
• Coding Standards
• Requirements Standards
• Design Standards
• Requirements Specification
• Design Description
• Unit Test Procedure
• Unit Test Plans
• Unit Test Reports
• Integration Test Procedure
• Integration Test Plan
• Integration Test Report
• Trace Matrices
• Configuration Index
• Software Accomplishments Summary
• Safety Manual