Alphabet Soup
This acronym stands for a systematic investigation into the root cause of an identified problem or risk to prevent its recurrence.
CAPA
In the United States, 21 CFR Part 820 governs the Quality System Regulation (QSR), which FDA recently harmonized with ISO 13485 under this new rule name.
QMSR
This visual root-cause analysis tool, named after a Japanese organizational theorist, resembles a sea creature's skeleton.
Fishbone
When revising an existing SOP or WI, this must be included to highlight substantive content modifications.
Redlines
Cleerly's products belong to this Medical Device Class
Class II
This is a fast, non-invasive heart imaging test that uses X-rays and an intravenous contrast dye to create detailed 3D pictures of the heart and coronary arteries
CCTA
This crucial ISO standard defines the application of risk management to medical devices throughout their entire lifecycle.
ISO 14971
This official FDA form is issued to firm management at the conclusion of an inspection when investigators observe conditions that may violate the FD&C Act.
Form 483
If a document is not updated for a period of 2 years, the process owner shall perform this to determine if updates are needed.
Periodic review
Cleerly was founded on this year
2017
The general term encompassing GMP, GLP, and GCP, representing the quality guidelines and regulations in life sciences.
GxP
This CFR Part specifically covers Electronic Records and Electronic Signatures.
Part 11
The technique of asking a core analytical question repeatedly to drill down to the fundamental cause of a failure.
5 Whys
This happens to a complaint if the customer or user does not respond to follow-up requests for information.
The complaint is closed and considered lost to follow up
This Department is responsible for generating clinical evidence for Regulatory Approval
Scientific Affairs
This abbreviation describes the core expectations for data integrity.
ALCOA
This is a technical report that provides practical, non-mandatory guidance on how to apply the medical device risk management standard
ISO/TR 24971
If an FDA Form 483 response is inadequate or the violations are severe, the agency issues this formal, publicly posted notification requesting prompt corrective action.
These 3 departments/groups are required to review all marketing materials.
Legal, Medical Affairs, and Regulatory
This department is typically excluded from the headcount reported to BSI.
Finance
Essential for design controls, this acronym stands for a living risk management document used to identify potential failure modes in a device's manufacturing or design process and evaluate their effects.
FMEA
This regulation fully replaced the Medical Device Directive (MDD) in May 2021, imposing stricter requirements on clinical evidence and post-market surveillance.
EU MDR
In MDSAP (Medical Device Single Audit Program), audits cover 5 participating countries. Name 3 of the 5 participating regulatory authorities.
US FDA, Health Canada, Japan PMDA/MHLW, Australia TGA, and Brazil ANVISA
This phase of the development lifecycle is when preliminary regulatory assessments are established.
The design phase
This executive is internationally recognized as a leader in AI for healthcare, with more than 40 peer-reviewed scientific publications and over 55 patents worldwide.
CTO