Glossary


DIACAP
DoD Information Assurance Certification and Accreditation Process

FDA
United States Food and Drug Administration (http://www.fda.gov/)

Harm
Physical injury or damage to the health of people, or damage to property or the environment.

Hazard
Potential source of harm.

IEC
International Electrotechnical Commission (http://www.iec.ch/)

IMDRF
International Medical Device Regulators Forum (http://www.imdrf.org/) . The IMDRF is taking on the work of the Global Harmonization Task Force (GHTF).

ISO
International Organization for Standardization (http://www.iso.org/)

Risk
Combination of the probability of occurrence of harm and the severity of that harm

SaMD
Software as a Medical Device

Scrum
Scrum is an Agile process framework for developing products. Scrum was defined by Ken Schwaber and Jeff Sutherland. – You can find links about Scrum on my “Agile Software Development Links” page http://www.adamdarmstadt.com/links/agile-software-development-links/)

SDLC
Software Development Life Cycle

SiMD
Software in a Medical Device

TSP
“Team Software Process (TSP) guides engineering teams that are developing software-intensive products. Using TSP helps organizations establish a mature and disciplined engineering practice that produces secure, reliable software in less time and at lower costs.” (From http://www.sei.cmu.edu/tsp/)