Medical Device Software Verification, Validation and Compliance . David A. Vogel
ISBN: 9781596934221 | 445 pages | 12 Mb
Medical Device Software Verification, Validation and Compliance David A. Vogel
Publisher: Artech House
The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software. Standards-developing agencies have also focused on the importance of applying Risk Management to medical devices in view of ensuring patient safety, most notably in the ISO 14971 standard. However, Risk Management is not just a Each participant in product development, whether an engineer, medical specialist, compliance specialist, or verification and validation expert, needs to be integrated into Risk Management. Mark Crawford of Pilgrim Software recently conducted a Q&A with Capaccio's Wayne Bates regarding sustainability and the medical device industry. The FDA's analysis of medical device recalls reveals that nearly 8% of them are Other design controls, such as planning, input, verification, and reviews, are required for medical device software. Validation sets a high degree of assurance that a software product, service, or system accomplishes its intended requirements avoiding defects and recals. Requirement-based testing at unit level is central to ISO 26262 compliance, as it is highly recommended for all ASIL levels. AMERICA ONE specializes in helping companies assure their compliance with FDA and global regulations. It is not intended to be an exhaustive review of the . This document is intended to serve as a reference to show how the VectorCAST products from Vector Software can be used to satisfy the Verification and Validation requirements specified in the ISO 26262 standard, itself derived from IEC 61508 . Streamlining development processes while verifying software quality and complying with strict regulatory requirements is a challenge for medical device companies.