223
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8
9
10
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Global Medical Device Regulatory Strategy
standards, such as those developed and dissemi-
nated by ISO and IEC.
A standard is a not a regulation. A regu-
lation is a national rule implementing a law,
which, if violated, can result in a penalty. A
national regulatory body develops a regulation.
Figure 15-1 presents a graphic representation
of the hierarchical relationship between reg-
ulations, guidance documents, standards and
technical reports. It is important to remem-
ber regulatory agencies issue regulations and
guidance documents, while SDOs, which are
nongovernmental entities, issue standards and
technical reports.
Product Standards and Process
Standards
Standards can be grouped into three major
categories: compatibility, process and safety and
performance. Universal serial bus (USB) and
blue-ray disc standards are specific examples of
compatibility standards. Process standards cover
a medical device product’s lifecycle. Process
standards dictate a process or overall system’s
requirements but do not dictate how a medical
device manufacturer should meet these require-
ments. Standards also can be categorized as
vertical, collateral or horizontal. For medical
devices, horizontal standards would be “gen-
eral” standards applicable to almost all medical
devices. For example, ISO 13485 Quality
Systems, ISO 14971 Risk Management and ISO
15223 Symbols for Labelling would apply to
most regulated medical devices. The collateral
standards would be “group” standards applicable
to certain type of products. Examples would be
IEC 60601-1-2: Electromagnetic Disturbances:
Requirements and Tests and IEC 60601-1-3
Radiation Protection in Diagnostic X-Ray
Equipment. In contrast, vertical standards apply
to specific devices or device categories, such as
the IEC 60601-2 family of standards that apply
to certain electromechanical medical devices.
SDOs and professional associations have
developed and published numerous compat-
ibility, process and safety and performance
standards. Only standards relevant to the medi-
cal device lifecycle, from concept to market, are
within this chapter’s scope. While more than
1,000 standards are used in the medical device
industry, a few are worth profiling in this chap-
ter due to their broad usage and recognition.
These profiled standards, recognized and
referenced by multiple regulatory authorities
and generally applicable to all medium- to
high-risk medical devices, include ISO 13485,
ISO 14971 and IEC 62366 Medical Devices—
Application of Usability Engineering to Medical
Devices. IEC 62304 Medical Device Software—
Software Life Cycle Processes will be profiled and,
as the title indicates, is applicable to medical
devices containing software, standalone software
or mobile medical applications. Last but not
least, ISO 14155:2011 Clinical Investigation
of Medical Devices for Human Subjects—Good
Clinical Practice, also will be profiled in this
chapter, since clinical investigation is a critical
process by which a manufacturer collects safety
and performance data to support medical device
market approval.
ISO 13485—Medical Devices—Quality
Management Systems—Requirements for
Regulatory Purposes
ISO 13485 gives available quality management
system (QMS) requirements an organization can
use for medical device design and development,
production, installation and servicing and design-
ing, developing and providing related services.16
ISO 13485 is derived from historic versions
of ISO 9001 (versions prior to 2015), a standard
containing QMS requirements used around the
world for various manufacturing and service
Figure 15-1. Document Hierarchy
Laws
Regulations
Guidances
Standards
Technical Reports
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
19
16
20
17
21
18
22
Global Medical Device Regulatory Strategy
standards, such as those developed and dissemi-
nated by ISO and IEC.
A standard is a not a regulation. A regu-
lation is a national rule implementing a law,
which, if violated, can result in a penalty. A
national regulatory body develops a regulation.
Figure 15-1 presents a graphic representation
of the hierarchical relationship between reg-
ulations, guidance documents, standards and
technical reports. It is important to remem-
ber regulatory agencies issue regulations and
guidance documents, while SDOs, which are
nongovernmental entities, issue standards and
technical reports.
Product Standards and Process
Standards
Standards can be grouped into three major
categories: compatibility, process and safety and
performance. Universal serial bus (USB) and
blue-ray disc standards are specific examples of
compatibility standards. Process standards cover
a medical device product’s lifecycle. Process
standards dictate a process or overall system’s
requirements but do not dictate how a medical
device manufacturer should meet these require-
ments. Standards also can be categorized as
vertical, collateral or horizontal. For medical
devices, horizontal standards would be “gen-
eral” standards applicable to almost all medical
devices. For example, ISO 13485 Quality
Systems, ISO 14971 Risk Management and ISO
15223 Symbols for Labelling would apply to
most regulated medical devices. The collateral
standards would be “group” standards applicable
to certain type of products. Examples would be
IEC 60601-1-2: Electromagnetic Disturbances:
Requirements and Tests and IEC 60601-1-3
Radiation Protection in Diagnostic X-Ray
Equipment. In contrast, vertical standards apply
to specific devices or device categories, such as
the IEC 60601-2 family of standards that apply
to certain electromechanical medical devices.
SDOs and professional associations have
developed and published numerous compat-
ibility, process and safety and performance
standards. Only standards relevant to the medi-
cal device lifecycle, from concept to market, are
within this chapter’s scope. While more than
1,000 standards are used in the medical device
industry, a few are worth profiling in this chap-
ter due to their broad usage and recognition.
These profiled standards, recognized and
referenced by multiple regulatory authorities
and generally applicable to all medium- to
high-risk medical devices, include ISO 13485,
ISO 14971 and IEC 62366 Medical Devices—
Application of Usability Engineering to Medical
Devices. IEC 62304 Medical Device Software—
Software Life Cycle Processes will be profiled and,
as the title indicates, is applicable to medical
devices containing software, standalone software
or mobile medical applications. Last but not
least, ISO 14155:2011 Clinical Investigation
of Medical Devices for Human Subjects—Good
Clinical Practice, also will be profiled in this
chapter, since clinical investigation is a critical
process by which a manufacturer collects safety
and performance data to support medical device
market approval.
ISO 13485—Medical Devices—Quality
Management Systems—Requirements for
Regulatory Purposes
ISO 13485 gives available quality management
system (QMS) requirements an organization can
use for medical device design and development,
production, installation and servicing and design-
ing, developing and providing related services.16
ISO 13485 is derived from historic versions
of ISO 9001 (versions prior to 2015), a standard
containing QMS requirements used around the
world for various manufacturing and service
Figure 15-1. Document Hierarchy
Laws
Regulations
Guidances
Standards
Technical Reports