This article defines software verification and validation (V&V) for medical devices.
The article also provides an overview of the CE Marking application and 510k submission requirements for medical devices containing software.
“Intended Use” also ensures safety of the process through the process of “Hazard Analysis” whereby any hazard that could potentially cause harm to the patient/customer is identified.
For each identified hazard, software requirements, software design and other risk controls are used to make sure the hazard does not result in harm, or if it does, the severity of the harm is reduced as far as possible.
This baselines the V&V process roadmap utilized for FSW requirements definition, FSW development, and FSW mission preparation. The following documents are applicable to the requirements contained in this document.
“(Current Issue)” is shown in place of the specific date and issue when the document is under Level II PRCB control.
This is accomplished by rigorous and thorough software testing using prospectively approved software verification protocols.
To provide a basis for management of the program requirements, directives, procedures, interface agreements, and information regarding system capabilities are to be documented, baselined, and subsequently controlled by the proper management level.As with most medical device standards, the standard provides a risk-based approach for evaluation of SOUP acceptability and defines testing requirements for SOUP.For 510k submissions to the US FDA, section 16 of the 510k submission describes the software verification and validation (V&V) activities that have been conducted to ensure the software is safe and effective.Change authority and management of the implementation strategy for the Verification and Validation requirements and processes in NSTS 08271 are hereby delegated to WA/Space Shuttle Engineering Integration Office via the SASCB.Revisions to this plan will be made as required to incorporate baseline changes to NSTS 07700, Volume XVIII, Book 3. The purpose of this document is to define and establish the Space Shuttle Program baseline requirements for the Flight Software (FSW) Verification and Validation (V&V) process and to establish the activities and the responsible program elements in this process for both the Space Shuttle General Purpose Computer (GPC) and the Space Shuttle Main Engine (SSME).Software is not a piece of metal that can be put into a strain gauge to see if the code is strong enough not to break. You can’t see if it is in the process of failing until it fails.The FDA is concerned about software safety since many medical devices now include software.The top level policies and requirements for Flight Software Verification and Validation are contained in NSTS 07700, Volume XVIII, Computer Systems and Software Requirements, Book 3, Software Management and Control.All changes to NSTS 08271, Space Shuttle Program Flight Software Verification and Validation Requirements Document, in the form of change requests will be presented to the Shuttle Avionics Software Control Board (SASCB) for disposition.In order to be approved for CE Marking by a Notified Body, the device must meet the essential requirements defined in the applicable EU directive.The technical file must also include performance testing of the medical device in accordance with the “State of the Art.” For software, software – software life cycle processes, is considered “State of the Art” for development and maintenance of software for medical devices.