Advisory Notice
- Authorized
Representative - Clinical Evaluation
Complaint - Distributor - Implantable
Medical Device - Importer
- Labeling
Life-Cycle - Manufacturer - Medical Device - Medical Device Family
Performance Evaluation -
Postmarket Surveillance - Purchased
Product
Risk - Risk Management - Sterile Barrier System - Sterile Medical Device
We’ve translated both the ISO 13485 2016
and the ISO 9000 2015
definitions
into plain
English in order to make them easier to understand. We
include both
sets
of definitions because the new ISO 13485 standard
expects you to use both.
|
Advisory noticeOrganizations often issue advisory notices
after their medical devices have |
Authorized representativeAn authorized representative is a natural
or legal person who has received |
Clinical evaluationA clinical evaluation uses clinical
evidence to assess and to analyze |
ComplaintA complaint is a negative communication
about a medical device that
Complaints may also allege that a related service,
that affects
|
DistributorA distributor is any natural or legal
person who furthers the availability |
Implantable medical deviceAn implantable medical device is a medical
device that is partly or |
ImporterAn importer is any natural or legal person
who is responsible for taking |
LabellingLabelling (or labeling) is written, printed,
graphic, or electronic information |
Life-cycleThe life-cycle of a
medical device includes all phases from initial |
ManufacturerIn the context of this standard, a manufacturer
is any natural or legal Also, anyone who modifies a medical device or changes
its intended The term medical device manufacturer may
also include anyone Manufacturers have the legal responsibility
to comply with all relevant |
Medical deviceInstruments,
appliances, implements, implants, machines, software,
|
Medical device familyA medical
device family is a group of medical devices that
share the |
Performance evaluationIn the context of this
standard, a performance evaluation uses data |
Postmarket surveillancePostmarket
surveillance is a systematic process that is used
to collect |
Purchased product A
purchased product
is a product that was provided by someone
that is outside an organization's quality management
system.
|
RiskAccording to ISO 13485,
when the term risk is used it refers to the need
|
Risk managementAccording to ISO
14971, risk management uses policies,
procedures, |
Sterile barrier systemA sterile barrier
system is the minimum package that prevents |
Sterile medical deviceA sterile medical
device is a medical device that meets established
sterility |
OTHER
PLAIN ENGLISH MANAGEMENT DICTIONARIES |
Introduction to ISO 13485 2016 Outline of ISO 13485 2016 Standard Overview of ISO 13485 2016 Standard ISO 13485 2016 versus ISO 13485 2003 ISO 13485 2016 Translated into Plain English |
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Updated on April 17, 2021. First published on June 30, 2015. |
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