Quality Progress - May 2017 - 12

Zooming in on industry-specific issues

eld Notes
FDA REGULATION

Sorting It
Out
Medical device risk management is an interesting and
rewarding profession because we perform critical analyses throughout a product's life cycle to protect patients
and users from harm. Risk management also can be a challenging subject as a technical field and as a topic that elicits
many opinions and emotions regarding specific implementation details.
In 2012, the European standard, EN ISO 14971 Risk management for medical devices,1 was revised and has become
the standard for organizations throughout much of the
world. However, ISO 14971-Medical devices-application
of risk management to medical devices2 (no EN) was last
revised in 2007 and remains the standard for organizations
in the United States.
Within the last few years, there have been several U.S.
guidance documents and technical information reports
(TIR) issued that solely recognize ISO 14971:2007, which
further muddies the waters with respect to how a global
organization can best demonstrate compliance to the EN
and non-EN version of ISO 14971 within the confines of a
simple quality system.
Compounding that duality challenge is the people side
of medical device work. Unlike some technical subjects,

12 QP

May 2017 ❘ qualityprogress.com

Making sense of the many guidance
documents, standards related to medical
device risk management
by Scott A. Laman

decisions regarding the
application of risk management are often not black and
white-there are many ways
to demonstrate compliance.
In addition, risk management is intuitive because
we apply the concepts in
most areas of our lives. For
example, we routinely and
subconsciously estimate the
severity of some form of harm
and the probability of some
type of cause, whether the
subject is medical, financial,
relational or driving a car.
Therefore, we are all experts
in the general application
of risk management, which
can make it difficult to obtain
consensus in a medical device
business across all geographies and divisions.

ISO 14971 basics

The basic deliverables of
ISO 14971 are clear: a risk
management plan, a risk
analysis or analyses of various
types that meet the detailed
requirements, a risk management report, and a system
to collect and review production and post-production
information, all of which are
to be documented in the risk
management file. None of
that changed with EN ISO
14971:2012. However, the
2012 revision goes above and
beyond in several areas.
The purpose of EN ISO
14971:2012 was to establish
consistency with European
Union Medical Device Directive, 93/42/European
Economic Community (EEC),3


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Table of Contents for the Digital Edition of Quality Progress - May 2017

Seen and Heard
Expert Answers
Progress Report
Mr. Pareto Head
Field Notes
Mind the Gaps
Solid Footing
Are These the Same?
New Tricks for an Old Tool
Innovation Imperative
Experience More
Career Coach
Statistics Spotlight
Standard Issues
Marketplace
Footnotes
Back to Basics
Quality Progress - May 2017 - intro
Quality Progress - May 2017 - cover1
Quality Progress - May 2017 - cover2
Quality Progress - May 2017 - 1
Quality Progress - May 2017 - 2
Quality Progress - May 2017 - 3
Quality Progress - May 2017 - 4
Quality Progress - May 2017 - 5
Quality Progress - May 2017 - Seen and Heard
Quality Progress - May 2017 - Expert Answers
Quality Progress - May 2017 - Progress Report
Quality Progress - May 2017 - Mr. Pareto Head
Quality Progress - May 2017 - 10
Quality Progress - May 2017 - 11
Quality Progress - May 2017 - Field Notes
Quality Progress - May 2017 - 13
Quality Progress - May 2017 - 14
Quality Progress - May 2017 - 15
Quality Progress - May 2017 - Mind the Gaps
Quality Progress - May 2017 - 17
Quality Progress - May 2017 - 18
Quality Progress - May 2017 - 19
Quality Progress - May 2017 - 20
Quality Progress - May 2017 - 21
Quality Progress - May 2017 - 22
Quality Progress - May 2017 - 23
Quality Progress - May 2017 - Solid Footing
Quality Progress - May 2017 - 25
Quality Progress - May 2017 - 26
Quality Progress - May 2017 - 27
Quality Progress - May 2017 - 28
Quality Progress - May 2017 - 29
Quality Progress - May 2017 - Are These the Same?
Quality Progress - May 2017 - 31
Quality Progress - May 2017 - 32
Quality Progress - May 2017 - 33
Quality Progress - May 2017 - 34
Quality Progress - May 2017 - 35
Quality Progress - May 2017 - New Tricks for an Old Tool
Quality Progress - May 2017 - 37
Quality Progress - May 2017 - 38
Quality Progress - May 2017 - 39
Quality Progress - May 2017 - 40
Quality Progress - May 2017 - 41
Quality Progress - May 2017 - 42
Quality Progress - May 2017 - 43
Quality Progress - May 2017 - Innovation Imperative
Quality Progress - May 2017 - 45
Quality Progress - May 2017 - 46
Quality Progress - May 2017 - Career Coach
Quality Progress - May 2017 - 48
Quality Progress - May 2017 - 49
Quality Progress - May 2017 - Statistics Spotlight
Quality Progress - May 2017 - 51
Quality Progress - May 2017 - 52
Quality Progress - May 2017 - 53
Quality Progress - May 2017 - Standard Issues
Quality Progress - May 2017 - 55
Quality Progress - May 2017 - 56
Quality Progress - May 2017 - 57
Quality Progress - May 2017 - Marketplace
Quality Progress - May 2017 - 59
Quality Progress - May 2017 - Footnotes
Quality Progress - May 2017 - 61
Quality Progress - May 2017 - 62
Quality Progress - May 2017 - 63
Quality Progress - May 2017 - Back to Basics
Quality Progress - May 2017 - cover3
Quality Progress - May 2017 - cover4
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