Zenith Quality Assessors Pvt. Ltd.

EXERCISE 01
Medical Devices - Quality management systems -
Requirements for regulatory purposes (ISO 13485:2016) - Terms and Definitions (Matching
Exercise)

First name / Surname Date

Number of questions Maximum points:

20 20

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Zenith Quality Assessors Pvt. Ltd.
Match the followings MD-QMS Terms and Definitions:
Identify the alphabet matching with the s. no. E.g.: 1 = B

S. MD-QMS S. MD-QMS DEFINITIONS Answer

No. TERMS No.
1 Advisory A Written, electronic or oral communication that
Notice alleges deficiencies related to the identity,
quality, durability, reliability, usability, safety or
performance of a medical device that has been
related from the organization’s control or related
to a service that affects the performance of such
medical device
2 Authorized B Medical device which can only be removed
representativ by medical or surgical intervention and which
e is intended to;
 Be totally or partially introduced into
the human body or a natural orifice, or
 Replace an epithelial surface or surface
of the eye, and
 Remain after the procedure for at least
30 days
3 Clinical C Natural or legal person in the supply chain who
evaluation is the first in a supply chain to make a medical
device, manufactured in another country or
jurisdiction, available in the country or
jurisdiction where it is to be marketed.
4 Complaint D Label, instructions for use, and any other
information that is related to identification,
technical description, intended purpose and
proper use of the medical device, but excluding
shipping documents.
5 Distributor E Natural or Legal person with responsibility for
design and / or manufacture of a medical device
with the intention of making the medical device
available for use, under his name; Whether or not
such a medical device is designed and / or
manufactured by that person himself or on his
behalf by another
person(s).
6 Implantable F Minimum package that prevents ingress of
Medical microorganisms and allows aseptic presentation of
Device the product at the point of use

7 Importer G Notice issued by the organization, subsequent

delivery of the medical device, to provide
supplementary information or to advice on
action to be taken in the:
 Use of medical device,
 Modification of a medical device,
 Return of the medical device to the
organization that supplied it, or

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Zenith Quality Assessors Pvt. Ltd.
S. MD-QMS S. MD-QMS DEFINITIONS Answer
No. TERMS No.
Destruction of a medical device
8 Labeling H Assessment and analysis of clinical data
pertaining to a medical device to verify the
clinical safety and performance of the device
when used as intended
by the manufacturer.
9 Lifecycle I Natural or legal person in the supply chain who,
on his own behalf, furthers the availability of a
medical device to the end user.

10 Manufacturer J Part of Quality Management, focused on

providing confidence that the quality
requirements will be fulfilled.

11 Medical K assessment and analysis of data to establish or

device verify the ability of an in vitro diagnostic medical
device to achieve its intended use

12 Requirement L Systematic process to collect and analyse

experience gained from medical device that
have been placed on the market.

14 Post Market N Instrument, apparatus, implement, machine,

surveillance appliance, implant, reagent for in vitro use,
software, material or other similar or related
article, intended by the manufacturer to be used,
alone or in combination, for human beings, for
one or more of the specific medical purpose(s)
of;
 Diagnosis, prevention, monitoring,
treatment or alleviation of disease;
 Diagnosis, monitoring, treatment,
alleviation of or compensation for an
inquiry;
 Investigation, replacement, modification,
or support of the anatomy or of a
physiological process;
 Supporting or sustaining life;
 Control of conception;
 Disinfection of medical devices;
 Providing information by means of in vitro
examination of specimens derived from
the human body;
And does not achieve its primary intended
action by pharmacological, immunological, or
metabolic means, in or on the human body, but
which may be assisted in its intended function

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Zenith Quality Assessors Pvt. Ltd.
S. MD-QMS S. MD-QMS DEFINITIONS Answer
No. TERMS No.
by such means.
13 Performance M Result of a process
evaluation

15 Quality O All phases in the life of a medical device, from

Assurance the initial conception to final decommissioning
and disposal

16 Purchased P Need or expectation that is stated, generally

Product implied or obligatory.

17 Risk Q Product provided by a party outside the

Management organization’s Quality Management System

18 Sterile Barrier R Systematic application of management policies,

System procedures, and practices to the tasks of
analyzing, evaluating, controlling, and monitoring
risk.

19 Quality S Medical device intended to meet the requirements

for sterility

20 Sterile T Degree to which a set of inherent characteristics

Medical of an object fulfills requirements.
Device

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