226
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
Quality Management and Corresponding General
Aspects for Medical Devices. IEC TR 80002-1 is
extremely helpful in understanding how to apply
risk management principles in ISO 14971 to
medical device software.
ISO 14155:2011 Clinical Investigation of
Medical Devices for Human Subjects—Good
Clinical Practice
ISO 14155 is intended to ensure Good Clinical
Practice (GCP) is followed during a medical
device clinical investigation to ensure subject
safety.
ISO 14155 details the baseline clinical
investigation requirements for market approval
safely. Key stakeholders, e.g., the sponsor and
principal investigators, are required to follow
the standard’s requirements. Recognized by
FDA, ISO 14155 can be applied in parallel with
FDA’s GCP and guidance on an investigational
device exemption (IDE) however, it should
be noted, while consistent with FDA’s GCP
requirements, conformity with ISO 14155 alone
is insufficient for US clinical investigations.
Further, conformity with ISO 14155 may not
be sufficient for FDA to accept data from clin-
ical investigations conducted outside the US. A
medical device global regulatory professional
must understand the common principles in all
these documents are pertinent when a medical
device is investigational, i.e., undergoing safety
and performance evaluations, under applicable
laws and GCP.
Some of the additional normative stan-
dards referenced in ISO 14155 are ISO 13485,
ISO 10993, ISO 15223 Symbols to be Used With
Medical Device Labels, Labeling and Information
to be Supplied, Part 1—General Requirements
and EN 1041 Information Supplied by the
Manufacturer of the Medical Device. A regulatory
professional must not assume however, that
normative references in a standard are recog-
nized automatically.
Benefits of Using Standards
The Standards and Conformity Assessment
Program22
A key reason for complying with standards and
integrating them into product development
is to enable an easier approval process with
regulatory bodies. Standards are voluntary
but, in some jurisdictions, have a particular
regulatory status and are recognized as a (the)
preferred means by which the manufacturer
may demonstrate conformity with the manda-
tory regulatory requirements. Thus, it generally
is easier to conform to the standard instead of
providing justification for not using it.
Standards play an important role through-
out the medical device lifecycle. Various
standard types exist to support all involved
medical device products and processes, such
as risk management and quality systems.
Multiple medical device industry stakehold-
ers are involved in developing standards and
stay involved in updating them as necessary.
Standards help harmonize regulatory processes
to ensure medical devices’ safety and perfor-
mance are not compromised at any point during
their lifecycle, playing an important role during
medical device and diagnostic product confor-
mity assessments.
As mentioned above, various standards
exist to support medical device processes and
can help manufacturers streamline their risk
management processes. Standards generally are
established to promote consistency and best
practices leading to devices meeting current
safety and effectiveness state-of-the-art expec-
tations. Designing to a standard can mitigate
potential application (use) and design risks.
For example, a device’s electrical power results
in risks associated with shock hazards. UL
60601-1 Medical Electrical Equipment, Part 1:
General Requirements for Safety, outlines stan-
dards for electrical safety protection methods
designing a device to comply with this standard
can be documented as mitigation measures
taken for shock hazard risks. This documenta-
tion also can support ISO 14971 requirements,
the medical device risk management standard.
In the US, FDA’s guidance, Center for
Devices and Radiological Health (CDRH)
Standard Operating Procedures for Identification
of Candidate Consensus Standards for Recognition,
provides an established process for standards’
recognition.23 A Standards Task Group (STG),
reporting to the Standard Management Staff
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
Quality Management and Corresponding General
Aspects for Medical Devices. IEC TR 80002-1 is
extremely helpful in understanding how to apply
risk management principles in ISO 14971 to
medical device software.
ISO 14155:2011 Clinical Investigation of
Medical Devices for Human Subjects—Good
Clinical Practice
ISO 14155 is intended to ensure Good Clinical
Practice (GCP) is followed during a medical
device clinical investigation to ensure subject
safety.
ISO 14155 details the baseline clinical
investigation requirements for market approval
safely. Key stakeholders, e.g., the sponsor and
principal investigators, are required to follow
the standard’s requirements. Recognized by
FDA, ISO 14155 can be applied in parallel with
FDA’s GCP and guidance on an investigational
device exemption (IDE) however, it should
be noted, while consistent with FDA’s GCP
requirements, conformity with ISO 14155 alone
is insufficient for US clinical investigations.
Further, conformity with ISO 14155 may not
be sufficient for FDA to accept data from clin-
ical investigations conducted outside the US. A
medical device global regulatory professional
must understand the common principles in all
these documents are pertinent when a medical
device is investigational, i.e., undergoing safety
and performance evaluations, under applicable
laws and GCP.
Some of the additional normative stan-
dards referenced in ISO 14155 are ISO 13485,
ISO 10993, ISO 15223 Symbols to be Used With
Medical Device Labels, Labeling and Information
to be Supplied, Part 1—General Requirements
and EN 1041 Information Supplied by the
Manufacturer of the Medical Device. A regulatory
professional must not assume however, that
normative references in a standard are recog-
nized automatically.
Benefits of Using Standards
The Standards and Conformity Assessment
Program22
A key reason for complying with standards and
integrating them into product development
is to enable an easier approval process with
regulatory bodies. Standards are voluntary
but, in some jurisdictions, have a particular
regulatory status and are recognized as a (the)
preferred means by which the manufacturer
may demonstrate conformity with the manda-
tory regulatory requirements. Thus, it generally
is easier to conform to the standard instead of
providing justification for not using it.
Standards play an important role through-
out the medical device lifecycle. Various
standard types exist to support all involved
medical device products and processes, such
as risk management and quality systems.
Multiple medical device industry stakehold-
ers are involved in developing standards and
stay involved in updating them as necessary.
Standards help harmonize regulatory processes
to ensure medical devices’ safety and perfor-
mance are not compromised at any point during
their lifecycle, playing an important role during
medical device and diagnostic product confor-
mity assessments.
As mentioned above, various standards
exist to support medical device processes and
can help manufacturers streamline their risk
management processes. Standards generally are
established to promote consistency and best
practices leading to devices meeting current
safety and effectiveness state-of-the-art expec-
tations. Designing to a standard can mitigate
potential application (use) and design risks.
For example, a device’s electrical power results
in risks associated with shock hazards. UL
60601-1 Medical Electrical Equipment, Part 1:
General Requirements for Safety, outlines stan-
dards for electrical safety protection methods
designing a device to comply with this standard
can be documented as mitigation measures
taken for shock hazard risks. This documenta-
tion also can support ISO 14971 requirements,
the medical device risk management standard.
In the US, FDA’s guidance, Center for
Devices and Radiological Health (CDRH)
Standard Operating Procedures for Identification
of Candidate Consensus Standards for Recognition,
provides an established process for standards’
recognition.23 A Standards Task Group (STG),
reporting to the Standard Management Staff