Absolutes & Acronyms

The few absolutes of this Industry

As in life, there are very few absolutes and constants in the auditing and medical device industry. However, those that are, are inescapable:

Death, Taxes, Audits, Nonconformities, Paperwork, and ACRONYMS!

Perhaps the only true love of this industry is that the authorities having jurisdiction certainly have a fondness for acronyms and have turned the global industry into a veritable alphabet soup.

The issue with so many Acronyms

For example, ‘MDR’…

F.D.A.- means Medical Device Reporting

E.U.- means Medical Device Regulations, I.E. Regulation (EU) 2017/745, also known as ‘the MDR’.

Depending on what niche of the medical system you’re in, it could also mean “Multi-Drug Resistance”, or “Medical Device Register”.

Medical Device Academy is based out of the United States. This means that it is plausible for us to refer to the CMDR or Canadian Medical Device Regulations. However, when interacting with Health Canada just MDR is often used. The ‘C’ is just assumed.

The meaning behind MDR also Differs

Continuing with ‘MDR’, what this acronym from the FDA means is referred to as something else by different authorities.

What the F.D.A. refers to when addressing Medical Device Reporting is not universal.

Comparably, Health Canada has requirements for Mandatory Problem Reporting. Which in turn is comparable to Vigilance Reporting in the E.U.

The best practical experience I can relate is that many years ago when I was an EMT, U/A was shorthand in our medical reports for ‘Upon Arrival’. That was fine for us, but one of our hospitals had assigned that acronym to mean ‘Urine Analysis’.

The important take away from this is that when in doubt skip the acronyms and use full titles in order to make sure everyone is clear on what exactly you are trying to communicate.

Acronyms

Consider the list below a far from all inclusive compilation of some of the more common acronyms and what they stand for:

13485– ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes.
QMS– Quality Management System.
CAPA– Corrective and Preventive Action.
QSR– Quality System Requirements, I.E., 21 CFR 820 Quality System Requirements, used by the U.S. FDA.
483– FDA Form 483 used as a warning letter for observation of nonconformity noted during FDA inspection.
OFI– Opportunity for Improvement.
MDSAP– Medical Device Single Audit Program
QSIT– Quality System Inspection Technique
NC– Nonconformity
QA/RA– Quality Assurance/Regulatory Affairs
GHTF– Global Harmonization Task Force
IMDRF– International Medical Device Regulators Forum
MDD– Medical Device Directives
AHJ– Authority Having Jurisdiction
AR– Authorized Representative
(EU) MDR– Medical Device Regulations (Regulation (EU) 2017/745)
(EU) IVDR– In-Vitro Diagnostic Regulations (Regulation (EU) 2017/746)
ISO– International Standards Organization
IEC– International Electrotechnical Commission
MDCG– Medical Device Coordinators Group
RAPS– Regulatory Affairs Professionals Society
AAMI– Association for the Advancement of Medical Instrumentation
MDA– Medical Device Academy ; )