Cepheid Quality Week Jeopardy Game 1

Risk Management

100

Cepheid's Risk Management SOP

What is D0077?

200

FMEA stands for

What is Failure Mode Effects Analysis?

300

Replaces cFMEA

What is Product Security Risk Assessment?

400

Medical Device Risk Management ISO standard

What is ISO 14971?

500

RPN stands for

What is risk priority number?

Software Quality

100

Cepheid's Software Design Control SOP

What is D0058?

200

SRS stands for

What is software requirements specification?

300

IEC's de facto software lifecycle guidance

What is IEC 62304?

400

Cepheid's New Agile Process for Software Lifecycle

What is D72055?    

500

SBOM stands for

What is Software Bill of Materials?

Agile Workflows Stands For

100

VWF

What is validation workflow?

200

AWF

What is approval workflow?

300

DCO

What is design change order?

400

UAWF

What is urgent approval workflow?

500

SAWF

What is supplier approval workflow?

Standards Titles

100

IEC 61010 title

What is Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use?

200

ISO 13485 title

What is Medical devices — Quality management systems — Requirements for regulatory purposes?

300

ISO 27001 title

What is Information Security Management?

400

ISO 14971 title

What is Medical devices — Application of risk management to medical devices?

500

ISO 42001 title

What is Information technology — Artificial intelligence — Management system?

QRC

100

QMS

What is Quality Management System?

200

IDE

Investigational Device Exemption

300

A form of FDA clearance

What is 510(k)?

400

CFR

Code of Federal Regulation

500

PMS

What is Post Market Surveillance?