Abbreviations and Definitions

Abbreviations

• GIAB: Genome In A Bottle
• FMEA: Failure Mode and Effects Analysis
• GDPR: General Data Protection Regulation
• IEC: International Electrotechnical Commission
• IGV: Integrative Genomics Viewer
• IMDRF: International Medical Device Regulators Forum
• ISO: International Organization for Standardization
• IVDR: In Vitro Diagnostics Regulation
• MDR: Medical Device Regulation
• MDSW: Medical Device SoftWare
• QMS: Quality Management System
• SAFER: Stop, Assess, Formulate, Execute, and Review
• SaMD: Software as a Medical Device
• SDLC: Software Development Life Cycle
• SMART: Specific, Measurable, Achievable, Realistic, and Timely
• SOP: Standard Operating Procedure
• SOUP: Software of Unknown Provenance
• WES: Whole Exome Sequencing

Definitions

• End users - The group that will actually use the software developed by bioinformaticians
• Git - A distributed version control system that tracks changes in any set of computer files.