Information sharing on Software

validation

Albert T.W. Li
Industrial Technology Research Institute
Center for Measurement Standards
4th Joint Conference of Taiwan and Japan on Medical Products
Regulation

Tokyo 7 Dec 2016

 Brief History of Software
• 2400 BCE Abacus in Babylon
• 1185~1005 BCE Abacus in Zhou Dynasty, China,
• 500 BCE Abacus in Ancient India,
• 1822 First mechanical computer invented by English mathematician Charles
Babbage
• 1911 IBM founded from a merger of several companies
• 1939 First digital computer “Atanasoff-Berry Computer”
• 1940 First programmable digital computer “Colossus”
• 1955 Computer Usage Company founded, first to sell software separately from
computer hardware/1957 ADP uses IBM mainframe computers to process pay roll
• 1972 SAP founded, first to sell enterprise software/1975 Microsoft founded/1976
Apple I/1977 Oracle developed/1978 first accounting software
“Peachtree”/1979 first spreadsheet software “Visicalc”
• 1989 Microsoft Office
• 1991 Linux /1993 first web browser “Mosaic”
• 2000”Dot-Com” bubble burst/2006 Google apps/2007 iPhone/ 2007 rise of big
data
• 2010 Rise of tablet computing/ 2012 Rise of wearable technology
• 2016 Intel: “The end of Moore's law”’ Source: 九章數學教育基金會，Wikipedia

Copyright 2016 ITRI 工業技術研究院 2

 Outline

1. Software in Medical Device Regulation

2. Software Standards and Guidance
3. Software Validation

Disclaimer: this presentation is prepared by ITRI for the purpose of 4th Joint Conference of Taiwan and
Japan on Medical Products Regulation . For official translation and interpretation of act and regulation,
please refer to Taiwan FDA.

Copyright 2016 ITRI 工業技術研究院 3

 Software in Medical Device Regulation

1) Software as medical device

2) QMS software
3) Production and service software
4) Software as result of a process

NOTE:
1. There are other concerns such as electronic signature and clinical trial
management system.
2. For electronic signature, refer to law/regulation of each jurisdiction such as 電子
簽章法(Electronic Signatures Act) of R.O.C. or 電子署名及び認証業務に関する法律
of Japan
3. For clinical trial management system, refer to US FDA guidance Computerized
Systems Used in Clinical Investigations, 2007.

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 1) Software as a Medical Device
• ISO 13485: 2016 3.11 medical device
instrument, apparatus, implement, machine, 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 injury;
— 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;

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 1) Software as a Medical Device
• IMDRF/SaMDWG/N10FINAL:2013 Software as a Medical
Device (SaMD): Key Definitions 5.1 Software as a Medical
Device
The term “Software as a Medical Device” (SaMD) is defined as
software intended to be used for one or more medical purposes
that perform these purposes without being part of a hardware
medical device.

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 1) Software as a Medical Device
• IMDRF/SaMDWG/N10FINAL:2013 Software as a Medical
Device (SaMD): Key Definitions 5.1 Software as a Medical
Device
NOTES
• SaMD is a medical device and includes in-vitro diagnostic (IVD) medical
device.
• SaMD is capable of running on general purpose (non-medical purpose)
computing platforms
• “without being part of” means software not necessary for a hardware
medical device to achieve its intended medical purpose;
• Software does not meet the definition of SaMD if its intended purpose is to
drive a hardware medical device
• SaMD may be used in combination (e.g., as a module) with other products
including medical devices;
• SaMD may be interfaced with other medical devices, including hardware
medical devices and
• other SaMD software, as well as general purpose software
• Mobile apps that meet the definition above are considered SaMD

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 Medical Device Software
• Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices, 2005, Scope
– For the purposes of this document, we refer to devices that contain
one or more software components, parts, or accessories, or are
composed solely of software as “software devices,” including:
• firmware and other means for software-based control of medical devices
• stand-alone software applications
• software intended for installation in general-purpose computers
• dedicated hardware/software medical devices.
• accessories to medical devices when those accessories contain or are
composed of software
• IEC 62304:2006 Medical device software—Software life cycle
processes, Scope (1.2 Filed of application)
– software is itself a medical device
– software is an embedded or integral part of the final medical device

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 1) Software as a Medical Device

• Article 13 Pharmaceutical Affairs Act (R.O.C.)

The term "medical device", as used in this Act, shall refer to any
instruments, machines, apparatus, materials, software, reagent for in
vitro use, and other similar or related articles, which is used in
diagnosing, curing, alleviating, or directly preventing human diseases,
regulating fertility, or which may affect the body structure or functions
of human beings, and do not achieve its primary intended function by
pharmacological, immunological or metabolic means in or on the
human body.

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 2) QMS Software

ISO 13485: 2016 4.1.6

The organization shall document procedures for the validation of the
application of computer software used in the quality management
system. Such software applications shall be validated prior to initial use
and, as appropriate, after changes to such software or its application.
The specific approach and activities associated with software validation
and revalidation shall be proportionate to the risk associated with the
use of the software.
Records of such activities shall be maintained (see 4.2.5).

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 3) Production and Service Software

ISO 13485: 2016 6.3 Infrastructure

The organization shall document the requirements for the
infrastructure needed to achieve conformity to product requirements,
prevent product mix-up and ensure orderly handling of product.
Infrastructure includes, as appropriate:
a) buildings, workspace and associated utilities;
b) process equipment (both hardware and software);
c) supporting services (such as transport, communication, or
information systems).
The organization shall document requirements for the maintenance
activities, including the interval of performing the maintenance
activities, when such maintenance activities, or lack thereof, can affect
product quality. As appropriate, the requirements shall apply to
equipment used in production, the control of the work environment
and monitoring and measurement.
Records of such maintenance shall be maintained (see 4.2.5).

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 3) Production and Service Software
ISO 13485: 2016 7.5.6 Validation of processes for production and
service provision
The organization shall validate any processes for production and
service provision where the resulting output cannot be or is not
verified by subsequent monitoring or measurement and, as a
consequence, deficiencies become apparent only after the product is
in use or the service has been delivered.
…
The organization shall document procedures for the validation of the
application of computer software used in production and service
provision. Such software applications shall be validated prior to initial
use and, as appropriate, after changes to such software or its
application. The specific approach and activities associated with
software validation and revalidation shall be proportionate to the risk
associated with the use of the software, including the effect on the
ability of the product to conform to specifications.
Records of the results and conclusion of validation and necessary
actions from the validation shall be maintained (see 4.2.4 and 4.2.5).

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 3) Production and Service Software
ISO 13485: 2016 7.6 Control of monitoring and measuring
equipment
…
The organization shall document procedures for the validation of the
application of computer software used for the monitoring and
measurement of requirements. Such software applications shall be
validated prior to initial use and, as appropriate, after changes to such
software or its application.
The specific approach and activities associated with software validation
and revalidation shall be proportionate to the risk associated with the
use of the software, including the effect on the ability of the product to
conform to specifications.
Records of the results and conclusion of validation and necessary
actions from the validation shall be maintained (see 4.2.4 and 4.2.5).

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 4) Software as Result of a Process
ISO 13485: 2016 3.15 product: result of a process
Note 1 to entry: There are four generic product categories, as follows:
— services (e.g. transport);
— software (e.g. computer program, dictionary);
— hardware (e.g. engine mechanical part);
— processed materials (e.g. lubricant).
Many products comprise elements belonging to different generic
product categories. Whether the product is then called service,
software, hardware or processed material depends on the dominant
element. For example, the offered product “automobile” consists of
hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid),
software (e.g. engine control software, driver’s manual), and service
(e.g. operating explanations given by the salesman).
Software consists of information and is generally intangible and can be
in the form of approaches, transactions or procedures.

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 Outline

1. Software in Medical Device Regulation

2. Software Standards and Guidance
3. Software Validation

Disclaimer: this presentation is prepared by ITRI for the purpose of 4th Joint Conference of Taiwan and
Japan on Medical Products Regulation . For official translation and interpretation of act and regulation,
please refer to Taiwan FDA.

Copyright 2016 ITRI 工業技術研究院 15

 Medical Device Software Concerns

• Software verification, validation and testing: life cycle process

• Software risk management
• Medical mobile apps
• Wireless
• Cybersecurity
• Interoperability

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 Medical Device Software Related Standards
Topics Software Related Standards
IEC 62304:2006+AMD1:2015 Medical device software - Software life cycle processes
AAMI TIR 45:2012 Guidance on the Use of AGILE Practices in the Development of Medical Device
Software life
Software
cycle processes
AAMI ANSI SW87:2012 Application of Quality Management System Concepts to Medical Device
Data Systems
IEC 80001-1 Edition 1.0 2010-10 Application of Risk Management for IT - Networks Incorporating
Medical Devices - Part 1: Roles, Responsibilities and Activities
IEC/TR 80002-1: 2009 Medical Device Software - Part 1: Guidance on the Application of ISO 14971
to Medical Device Software
IEC 80001-2-1 Edition 1.0 2012-07 Application of Risk Management for IT- Networks Incorporating
Medical Devices - Part 2-1: Step-By-Step Risk Management of Medical IT-Networks - Practical
Applications And Examples
IEC 80001-2-4 Edition 1.0 2012-11 Application of Risk Management for IT-Networks Incorporating
Risk
Medical Devices -- Part 2-4: Application Guidance - General Implementation Guidance for
Management
Healthcare Delivery Organization
IEC TR 80001-2-2 Edition 1.0 2012-07 Application of Risk Management for IT Networks
Incorporating Medical Devices - Part 2-2: Guidance for the Disclosure and Communication of
Medical Device Security Needs, Risks and Controls
IEC TR 80001-2-3 Edition 1.0 2012-07 Application of Risk Management for IT Networks
Incorporating Medical Devices - Part 2-3: Guidance for Wireless Networks
IEC TR 80001-2-5 2014 Application of Risk Management for IT-Networks Incorporating Medical
Devices Part 2-5: Application Guidance-- Guidance for Distributed Alarm Systems
IEC 62443-2-1: 2010 Industrial Communication Networks - Network And System Security - Part 2-1:
Establishing an Industrial Automation And Control System Security Program
IEC/TS 62443-1-1:2009 Industrial Communication Networks - Network And System Security - Part
1-1: Terminology, Concepts and Models
Cybersecurity
IEC/TR 62443-3-1:2009 Industrial Communication Networks - Network And System Security - Part
3-1: Security Technologies For Industrial Automation And Control Systems
ISO 29147:2014 Information Technology - Security Techniques - Vulnerability Disclosure
ISO 30111:2013 Information Technology - Security Techniques - Vulnerability Handling Processes
Interoperability ISO/IEEE 11073 Health informatics - Medical / health device communication standards
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 US FDA
Medical Device Software Validation Related Guidance
Topics Guidance Date
General Wellness: Policy for Low Risk Devices - Draft Guidance for Industry and
General Wellness 2015.01.20
Food and Drug Administration Staff
Mobile Medical Applications - Guidance for Industry and Food and Drug
Mobile Apps 2015.02.09
Administration Staff
Software Validation General Principles of Software Validation 2002.01.11
and Premarket
Guidance for the Content of Premarket Submissions for Software Contained in
Submission 2005.05.11
Medical Devices
Guidance for Industry - Wireless Medical Telemetry Risks and
2000.09.27
Recommendations
Deciding When To Submit A 510(k) For A Change To An Existing Wireless
Wireless Technology 2000.11.30
Telemetry Medical Device: Final Guidance for FDA Reviewers and Industry
Radio Frequency Wireless Technology in Medical Devices - Guidance for
2013.08.14
Industry and Food and Drug Administration Staff
Information for Healthcare Organizations about FDA's Guidance for Industry:
Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) 2005.0209
Software
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS)
2005.01.14
Cybersecurity Software- Guidance for Industry
Content of Premarket Submissions for Management of Cybersecurity in Medical
2014.10.02
Devices - Guidance for Industry and Food and Drug Administration Staff
Postmarket Management of Cybersecurity in Medical Devices- Draft Guidance
2016.1.22
for Industry and Food and Drug Administration Staff
Design Considerations and Pre-market Submission Recommendations for
Interoperability Interoperable Medical Devices- Draft Guidance for Industry and Food and Drug 2016.1.26
Administration Staff

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 Outline

1. Software in Medical Device Regulation

2. Software Standards and Guidance
3. Software Validation

Disclaimer: this presentation is prepared by ITRI for the purpose of 4th Joint Conference of Taiwan and
Japan on Medical Products Regulation . For official translation and interpretation of act and regulation,
please refer to Taiwan FDA.

Copyright 2016 ITRI 工業技術研究院 19

 Software Validation

• The Quality System regulation is harmonized with ISO 8402:1994, which

treats "verification" and "validation" as separate and distinct terms. On
the other hand, many software engineering journal articles and
textbooks use the terms "verification" and "validation" interchangeably,
or in some cases refer to software "verification, validation, and testing
(VV&T)" as if it is a single concept, with no distinction among the three
terms.
• Software verification provides objective evidence that the design outputs
of a particular phase of the software development life cycle meet all of
the specified requirements for that phase. Software verification looks for
consistency, completeness, and correctness of the software and its
supporting documentation, as it is being developed, and provides
support for a subsequent conclusion that software is validated. Software
testing is one of many verification activities intended to confirm that
software development output meets its input requirements. Other
verification activities include various static and dynamic analyses, code
and document inspections, walkthroughs, and other techniques.

Source: 3.1.2 Verification and Validation, General Principles of Software Validation;,

2002 , US FDA

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 Software Validation
• Software validation is a part of the design validation for a finished
device, but is not separately defined in the Quality System regulation. For
purposes of this guidance, FDA considers software validation to be
"confirmation by examination and provision of objective evidence that
software specifications conform to user needs and intended uses, and
that the particular requirements implemented through software can be
consistently fulfilled." In practice, software validation activities may occur
both during, as well as at the end of the software development life cycle
to ensure that all requirements have been fulfilled. Since software is
usually part of a larger hardware system, the validation of software
typically includes evidence that all software requirements have been
implemented correctly and completely and are traceable to system
requirements. A conclusion that software is validated is highly dependent
upon comprehensive software testing, inspections, analyses, and other
verification tasks performed at each stage of the software development
life cycle. Testing of device software functionality in a simulated use
environment, and user site testing are typically included as components
of an overall design validation program for a software automated device.
Source: 3.1.2 Verification and Validation, General Principles of Software Validation;,
2002, USFDA
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 Software Validation

• Software verification and validation are difficult because a developer

cannot test forever, and it is hard to know how much evidence is enough.
In large measure, software validation is a matter of developing a "level of
confidence" that the device meets all requirements and user
expectations for the software automated functions and features of the
device. Measures such as defects found in specifications documents,
estimates of defects remaining, testing coverage, and other techniques
are all used to develop an acceptable level of confidence before shipping
the product. The level of confidence, and therefore the level of software
validation, verification, and testing effort needed, will vary depending
upon the safety risk (hazard) posed by the automated functions of the
device.

Source: 3.1.2 Verification and Validation, General Principles of Software Validation;,

2002, US FDA

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 Software in Medical Device Regulation

1) Software as medical device

2) QMS software
3) Production and service software
4) Software as result of a process

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 Reasons for recalls
(US FDA, FY 2010 – FY 2012)
Reasons for recalls Number Reasons for recalls Number

Equipment Maintenance 31
Nonconforming Material/Component 429
Process Change Control 31
Software Design(Device) 429
Software Change Control 24
Device Design 425
Software Design (Process) 22
Process Control 266
Component Design/Selection 144 PMA- Illegally Marketed 21

Employee Error 134 Labeling Change Control 19

Labeling Mixups/Errors 99 Packaging Design/Selection 18
Under Investigation by the Firm 81 Release of Material/Component Prior to
Receiving Test results 15
Process Design 77
Expiration Dating 15
Packaging Process Control 76
Vendor Change Control 12
Error In Labeling 59
Packaging 58 Packaging Change Control 8

Mix-up of Material/Components 49 Manufacturing Material Removal 8

Material/Component Contamination 47 Storage 7

Labeling Design 42 Environmental Control 6
Unknown/Undetermined by the Firm 6
Radiation Control for Health and Safety Act 41
Finished Device Change Control 4
Labeling False And Misleading 39
Reprocessing Controls 2
Component Change Control 37
Copyright 2016 ITRI 工業技術研究院 Source : (US FDA) Medical Device Recall Report FY2003 to FY2012 24
 IEC 62304: 2006 Medical device software –
Software life cycle processes
ROC US EU Japan China
IEC 62304:2006 IEC 62304:2006 EN/IEC JIS T 2304:2012 YY/T 0664-2008醫療
Medical device +AMD1:2015 62304:2006/AC:2008 Medical device 器械軟體-軟體生存週
software—Software Medical device software— 期過程(IEC 62304)
life cycle processes Medical device software—Software Software life cycle
software—Software life cycle processes processes
life cycle processes EN 62304 Q&A
Guidance (2013)

• IEC 62304 is based on IEC 62304

 ISO/IEC 12207:1995, Information
Technology –Software Life Cycle Quality Risk Software
Processes Control Management Engineering
 ANSI/AAMI/SW 68:2001, Medical
Device Software – Software Life Cycle
Processes (superseded std.)
• IEC 62304 Software life cycle processes
 Safety classification added. (3 classes
with specific tasks for each).

IEC 62304:2006+AMD1:2015 updates

• Legacy software
• Software safety classification with a risk- Regulatory requirements compliance
based approach

Copyright 2016 ITRI 工業技術研究院 Source: IEC 62304:2006+AMD1:2015Medical device software - Software life cycle processes 25
 IEC 62304: 2006 Medical device software –
Software life cycle processes

4. General requirements 7. Software risk management process

5. Software development process 8. Software configuration process

9. Software problem resolution

6. Software maintenance process
process

Source: IEC 62304:2006+AMD1:2015Medical device software - Software life cycle processes

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 IEC 62304: 2006 Medical device software –
Software life cycle processes

• QMS
General requirements • Risk management
• Software safety classification

• Planning
• Requirements analysis
Software development • Architectural design
process • Detailed design
• Unit implementation and
verification
• Integration and integration testing
• System testing, release

Source: IEC 62304:2006+AMD1:2015Medical device software - Software life cycle processes

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 IEC 62304: 2006 Medical device software –
Software life cycle processes

• Maintenance plan
Software maintenance
• Problem and modification analysis
process • Modification implementation

• Analysis of software contributing to

hazardous situations
Software risk • Risk control measures
management process • Verification of risk control measures
• Risk management of software
changes

Source: IEC 62304:2006+AMD1:2015Medical device software - Software life cycle processes

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 IEC 62304: 2006 Medical device software –
Software life cycle processes

• Configuration identification
Software configuration • Change control
process • Configuration status accounting

• Problem reports
• Investigate the problem
• Advise relevant parties
Software problem • Use change control process
resolution process • Maintain records
• Analyse problems for trends
• Verify software problem resolution
• Test documentation contents

Source: IEC 62304:2006+AMD1:2015Medical device software - Software life cycle processes

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 US FDA
Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices, 2005

Level of Concern Software Description FDA recommends that you use

risk identification and control
techniques described in
consensus standards such as
Planning Device Hazard ISO 14971.
Analysis
Software Development
Software Requirement
Environment Description
Specification (SRS)
Requirements Analysis
Software Design Device Architecture
Specification (SDS) Design
Implementation
Traceability Analysis

Testing
Verification and
Validation Analysis
Configuration
Unreserved Anomalies Management
(Bugs or Defects)
Revision History
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 IEC 62304 Safety Classification vs. FDA Level of
Concern
IEC 62304 Software Safety FDA Pre-market Submission
Classification Software Levels of Concern

Class A: No injury or damage to Minor: failure or latent design flaws

health is possible are unlikely to cause any injury

Class B: Non-serious injury is Moderate: failure or latent possible

possible design flaw could directly or
indirectly result in minor injury

Class C: Death of Serious injury is Major: failure or flaw could directly

possible or indirectly result in death or
serious injury

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 Software in Medical Device Regulation
1) Software as medical device
2) QMS software
3) Production and service software
4) Software as result of a process
• No specific standard or guidance for the validation of software
used in medical device QMS
• AAMI TIR36:2007, Validation of Software for Regulated Processes
provides tool box and examples.

NOTE: For pharmaceutical industry:

• 電腦化系統確效指導手冊, Taiwan Food and Drug Administration, 2002
• EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines Annex 11
Computerised Systems
• US FDA Guidance for Industry Process Validation: General Principles and Practices 2011
• WHO Supplementary Training Modules: Validation, Water, Air Handling Systems Validation
(Part 5): Computerized system validation
• GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, ISPE
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 Considerations on
Validation of Non-Medical Device Software

• Determine whether the software

• Is developed by the manufacturer
• Is developed by sub-contracted software developer
• Is developed by the manufacturer based on off-the-shelf
software
• Is purchased business software package
• Should be validated independently or with hardware
equipment

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 Validation of SW/HW Equipment

This guideline applies to processes which are

controlled by computers, but does not cover
software validation.
1) Form multi-functional team for validation
2) Plan the approach and define the requirements
3) Identify and describe the processes
4) Specify process parameters and desired output
5) Decide on verification and/or validation
6) Create a master validation plan
7) Select methods and tools for validation
8) Create validation protocols
9) Perform IQ, OQ, PQ and document results
10) Determine continuous process controls
11) Control the process continuously

Source: GHTF/SG3/N99 - 10:2004 (Edition 2)

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 Validation of SW/HW Equipment
2.1 Installation qualification (IQ): establishing by objective evidence that all key aspects
of the process equipment and ancillary system installation adhere to the
manufacturer’s approved specification and that the recommendations of the supplier
of the equipment are suitably considered.
2.2 Operational qualification (OQ): establishing by objective evidence process control
limits and action levels which result in product that meets all predetermined
requirements.
2.3 Performance qualification (PQ): establishing by objective evidence that the process,
under anticipated conditions, consistently produces a product which meets all
predetermined requirements.
2.4 Process validation: establishing by objective evidence that a process consistently
produces a result or product meeting its predetermined requirements.
2.5 Process validation protocol: a document stating how validation will be conducted,
including test parameters, product characteristics, manufacturing equipment, and
decision points on what constitutes acceptable test results.
2.6 Verification: confirmation by examination and provision of objective evidence that
the specified requirements have been fulfilled.

Source: GHTF/SG3/N99 - 10:2004 (Edition 2)

Copyright 2016 ITRI 工業技術研究院 35

 ご清聴ありがとうございました
謝謝聆聽，敬請指教

李子偉 [email protected]
廖盛惠 [email protected]

Copyright 2016 ITRI 工業技術研究院 36