Medical device software - Software life-cycle processes

This standard defines the life-cycle requirements for medical  device softare . The set of processes, activities, and tasks  described in this standard establishes a common framework  for medical device software life-cycle processes. This standard  applies to the development and maintenance of medical device  software. This standard may be used when software is itself a  medical device or when software is an embedded or integral  part of the final medical device.

Medizingeräte-Software - Software-Lebenszyklus-Prozesse

Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel

Définit les exigences du cycle de vie des logiciels de dispositifs médicaux. L'ensemble des processus, activités et tâches décrit dans la présente norme constitue un cadre commun pour les processus du cycle de vie des logiciels de dispositifs médicaux. S'applique au développement et à la maintenance des logiciels de dispositifs médicaux lorsque le logiciel est un dispositif médical ou lorsque le logiciel est incorporé ou fait partie intégrante du dispositif médical final. La présente norme ne couvre pas la validation et la mise sur le marché du dispositif médical, même lorsque le dispositif médical est intégralement constitué du logiciel.

Programska oprema za medicinske aparate – Procesi v življenjskem ciklu programske opreme (IEC 62304:2006)

Ta standard določa zahteve glede življenjskega cikla programske opreme za medicinske aparate. Nabor procesov, dejavnosti in opravil, opisanih v tem standardu, tvori skupno ogrodje za procese v življenjskem ciklu programske opreme za medicinske aparate. Ta standard se uporablja za razvoj in vzdrževanje programske opreme za medicinske aparate. Ta standard se lahko uporablja, kadar je programska oprema sama po sebi medicinskiaparat ali je vgrajen/sestavni del končne medicinskega aparata.

General Information

Status
Published
Publication Date
30-Sep-2006
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Oct-2006
Due Date
01-Oct-2006
Completion Date
01-Oct-2006

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SLOVENSKI SIST EN 62304:2006
STANDARD
oct 2006
Programska oprema za medicinske aparate – Procesi v življenjskem ciklu
programske opreme (IEC 62304:2006)
Medical device software - Software life-cycle processes (IEC 62304:2006)
ICS 13.020.60; 35.240.80 Referenčna številka
SIST EN 62304:2006(en)

© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
EN 62304
NORME EUROPÉENNE
July 2006
EUROPÄISCHE NORM
ICS 11.040
English version
Medical device software -
Software life-cycle processes
(IEC 62304:2006)
Logiciels de dispositifs médicaux - Medizingeräte-Software -
Processus du cycle de vie du logiciel Software-Lebenszyklus-Prozesse
(CEI 62304:2006) (IEC 62304:2006)

This European Standard was approved by CENELEC on 2006-06-01. CENELEC members are bound to comply

with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard

the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on

application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other

language made by translation under the responsibility of a CENELEC member into its own language and notified

to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech

Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,

Sweden, Switzerland and the United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 62304:2006 E
---------------------- Page: 2 ----------------------
EN 62304:2006 - 2 -
Foreword

The text of document 62A/523/FDIS, future edition 1 of IEC 62304, prepared by a joint working group of

SC 62A, Common aspects of electrical equipment used in medical practice, of IEC technical committee

62, Electrical equipment in medical practice, and ISO Technical Committee 210, Quality management

and corresponding general aspects for medical devices, was submitted to the IEC-CENELEC parallel

vote and was approved by CENELEC as EN 62304 on 2006-06-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2007-03-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2009-06-01
In this standard the following print types are used:
– requirements and definitions: in roman type;

– informative material appearing outside of tables, such as notes, examples and references: in smaller

type. Normative text of tables is also in a smaller type;

– terms used throughout this standard that have been defined in Clause 3 and also given in the index: IN

SMALL CAPITALS.

An asterisk (*) as the first character of a title or at the beginning of a paragraph indicates that there is

guidance related to that item in Annex B.
Table C.5 was prepared by ISO/IEC JTC 1/SC 7, Software and system engineering.
Annex ZA has been added by CENELEC.
__________
Endorsement notice

The text of the International Standard IEC 62304:2006 was approved by CENELEC as a European

Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards indicated:

IEC 60601-1-4 + A1 NOTE Harmonized as EN 60601-1-4:1996 + A1:1999 (not modified).

IEC 61508-3 NOTE Harmonized as EN 61508-3:2001 (not modified).
IEC 61010-1 NOTE Harmonized as EN 61010-1:2001 (not modified).
ISO 9000 NOTE Harmonized as EN ISO 9000:2005 (not modified).
ISO 9001 NOTE Harmonized as EN ISO 9001:2000 (not modified).
ISO 13485 NOTE Harmonized as EN ISO 13485:2003 (not modified).
IEC 60601-1-6 NOTE Harmonized as EN 60601-1-6:2004 (not modified).
__________
---------------------- Page: 3 ----------------------
- 3 - EN 62304:2006
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD

applies.
Publication Year Title EN/HD Year
1) 2)
ISO 14971 - Medical devices - Application of risk EN ISO 14971 2000
management to medical devices
Undated reference.
Valid edition at date of issue.
---------------------- Page: 4 ----------------------
IEC 62304
Edition 1.0 2006-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical device software – Software life cycle processes
Logiciels de dispositifs médicaux – Processus du cycle de vie du logiciel
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX
ICS 11.040 ISBN 2-8318-8637-6
---------------------- Page: 5 ----------------------
– 2 – 62304 © IEC:2006
62304  IEC:2006 – 3 –
CONTENTS

FOREWORD...........................................................................................................................4

INTRODUCTION....................................................................................................................6

1 Scope..............................................................................................................................9

1.1 * Purpose ...............................................................................................................9

1.2 * Field of application ...............................................................................................9

1.3 Relationship to other standards...............................................................................9

1.4 Compliance ............................................................................................................9

2 * Normative references ...................................................................................................10

3 * Terms and definitions ...................................................................................................10

4 * General requirements...................................................................................................14

4.1 * Quality management system................................................................................14

4.2 * RISK MANAGEMENT................................................................................................15

4.3 * Software safety classification...............................................................................15

5 Software development PROCESS ......................................................................................16

5.1 * Software development planning ...........................................................................16

5.2 * Software requirements analysis ...........................................................................18

5.3 * Software ARCHITECTURAL design ..........................................................................20

5.4 * Software detailed design .....................................................................................21

5.5 * SOFTWARE UNIT implementation and verification...................................................21

5.6 * Software integration and integration testing .........................................................22

5.7 * SOFTWARE SYSTEM testing....................................................................................24

5.8 * Software release .................................................................................................25

6 Software maintenance PROCESS ......................................................................................26

6.1 * Establish software maintenance plan ...................................................................26

6.2 * Problem and modification analysis.......................................................................26

6.3 * Modification implementation ................................................................................27

7 * Software RISK MANAGEMENT PROCESS ............................................................................28

7.1 * Analysis of software contributing to hazardous situations .....................................28

7.2 RISK CONTROL measures ........................................................................................29

7.3 VERIFICATION of RISK CONTROL measures................................................................29

7.4 RISK MANAGEMENT of software changes ..................................................................30

8 * Software configuration management PROCESS...............................................................30

8.1 * Configuration identification ..................................................................................30

8.2 * Change control....................................................................................................31

8.3 * Configuration status accounting...........................................................................31

9 * Software problem resolution PROCESS...........................................................................31

9.1 Prepare PROBLEM REPORTS.....................................................................................31

9.2 Investigate the problem..........................................................................................32

9.3 Advise relevant parties ..........................................................................................32

9.4 Use change control process...................................................................................32

9.5 Maintain records ....................................................................................................32

9.6 Analyse problems for trends ..................................................................................32

9.7 Verify software problem resolution .........................................................................33

9.8 Test documentation contents .................................................................................33

---------------------- Page: 6 ----------------------
62304 © IEC:2006 – 3 –
62304  IEC:2006 – 5 –

Annex A (informative) Rationale for the requirements of this standard..................................34

Annex B (informative) Guidance on the provisions of this standard ......................................37

Annex C (informative) Relationship to other standards........................................................53

Annex D (informative) Implementation ................................................................................74

Bibliography ........................................................................................................................

Index of defined terms.........................................................................................................77

Figure 1 – Overview of software development PROCESSES and ACTIVITIES...............................7

Figure 2 – Overview of software maintenance PROCESSES and ACTIVITIES...............................7

Figure B.1 – Example of partitioning of SOFTWARE ITEMS .......................................................42

Figure C.1 – Relationship of key MEDICAL DEVICE standards to IEC 62304 ............................54

Figure C.2 – Software as part of the V-model ......................................................................56

Figure C.3 – Application of IEC 62304 with IEC 61010-1......................................................66

Table A.1 – Summary of requirements by software safety class ............................................36

Table B.1 – Development (model) strategies as defined at ISO/IEC 12207............................38

Table C.1 – Relationship to ISO 13485:2003 .......................................................................54

Table C.2 – Relationship to ISO 14971:2000 ......................................................................55

Table C.3 – Relationship to IEC 60601-1 .............................................................................58

Table C.4 – Relationship to IEC 60601-1-4 ..........................................................................62

Table C.5 – Relationship to ISO/IEC 12207 .........................................................................68

Table D.1 – Checklist for small companies without a certified QMS......................................75

---------------------- Page: 7 ----------------------
– 4 – 62304 © IEC:2006
62304  IEC:2006 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICE SOFTWARE –
SOFTWARE LIFE CYCLE PROCESSES
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any

equipment declared to be in conformity with an IEC Publication.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 62304 has been prepared by a joint working group of subcommittee

62A: Common aspects of electrical equipment used in medical practice, of IEC technical

committee 62: Electrical equipment in medical practice and ISO Technical Committee 210,

MEDICAL DEVICES. Table C.5 was
Quality management and corresponding general aspects for
prepared by ISO/IEC JTC 1/SC 7, Software and system engineering.
It is published as a dual logo standard.
The text of this standard is based on the following documents:
FDIS Report on voting
62A/523/FDIS 62A/528/RVD

Full information on the voting for the approval of this standard can be found in the report on

voting indicated in the above table. In ISO, the standard has been approved by 23 P-members

out of 23 having cast a vote.
---------------------- Page: 8 ----------------------
62304 © IEC:2006 – 5 –
62304  IEC:2006 – 9 –

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this standard the following print types are used:
• requirements and definitions: in roman type;

• informative material appearing outside of tables, such as notes, examples and references:

in smaller type. Normative text of tables is also in a smaller type;

• terms used throughout this standard that have been defined in Clause 3 and also given in

the index: in small capitals.

An asterisk (*) as the first character of a title or at the beginning of a paragraph indicates that

there is guidance related to that item in Annex B.

The committee has decided that the contents of this publication will remain unchanged until the

maintenance result date indicated on the IEC web site under “http://webstore.iec.ch” in the data

related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
---------------------- Page: 9 ----------------------
– 6 – 62304 © IEC:2006
62304  IEC:2006 – 11 –
INTRODUCTION

Software is often an integral part of MEDICAL DEVICE technology. Establishing the SAFETY and

effectiveness of a MEDICAL DEVICE containing software requires knowledge of what the software

is intended to do and demonstration that the use of the software fulfils those intentions without

causing any unacceptable RISKS.

This standard provides a framework of life cycle PROCESSES with ACTIVITIES and TASKS

necessary for the safe design and maintenance of MEDICAL DEVICE SOFTWARE. This standard

provides requirements for each life cycle PROCESS. Each life cycle PROCESS is further divided

into a set of ACTIVITIES, with most ACTIVITIES further divided into a set of TASKS.

As a basic foundation it is assumed that MEDICAL DEVICE SOFTWARE is developed and

maintained within a quality management system (see 4.1) and a RISK MANAGEMENT system (see

4.2). The RISK MANAGEMENT PROCESS is already very well addressed by the International

Standard ISO 14971. Therefore IEC 62304 makes use of this advantage simply by a normative

reference to ISO 14971. Some minor additional RISK MANAGEMENT requirements are needed for

software, especially in the area of identification of contributing software factors related to

HAZARDS. These requirements are summarized and captured in Clause 7 as the software RISK

MANAGEMENT PROCESS.

Whether software is a contributing factor to a HAZARD is determined during the HAZARD

identification ACTIVITY of the RISK MANAGEMENT PROCESS. HAZARDS that could be indirectly

caused by software (for example, by providing misleading information that could cause

inappropriate treatment to be administered) need to be considered when determining whether

software is a contributing factor. The decision to use software to control RISK is made during

the RISK CONTROL ACTIVITY of the RISK MANAGEMENT PROCESS. The software RISK MANAGEMENT

PROCESS required in this standard has to be embedded in the device RISK MANAGEMENT

PROCESS according to ISO 14971.

The software development PROCESS consists of a number of ACTIVITIES. These ACTIVITIES are

shown in Figure 1 and described in Clause 5. Because many incidents in the field are related to

service or maintenance of MEDICAL DEVICE SYSTEMS including inappropriate software updates

and upgrades, the software maintenance PROCESS is considered to be as important as the

software development PROCESS. The software maintenance PROCESS is very similar to the

software development PROCESS. It is shown in Figure 2 and described in Clause 6.
---------------------- Page: 10 ----------------------
62304 © IEC:2006 – 7 –
62304  IEC:2006 – 13 –
IEC 722/06
Figure 1 – Overview of software development PROCESSES and ACTIVITIES
IEC 723/06
Figure 2 – Overview of software maintenance PROCESSES and ACTIVITIES

This standard identifies two additional PROCESSES considered essential for developing safe

MEDICAL DEVICE SOFTWARE. They are the software configuration management PROCESS (Clause

8) and the software problem resolution PROCESS (Clause 9).
---------------------- Page: 11 ----------------------
– 8 – 62304 © IEC:2006
62304  IEC:2006 – 15 –

This standard does not specify an organizational structure for the MANUFACTURER or which part

of the organization is to perform which PROCESS, ACTIVITY, or TASK. This standard requires only

that the PROCESS, ACTIVITY, or TASK be completed to establish compliance with this standard.

This standard does not prescribe the name, format, or explicit content of the documentation to

be produced. This standard requires documentation of TASKS, but the decision of how to

package this documentation is left to the user of the standard.

This standard does not prescribe a specific life cycle model. The users of this standard are

responsible for selecting a life cycle model for the software project and for mapping the

PROCESSES, ACTIVITIES, and TASKS in this standard onto that model.

Annex A provides rationale for the clauses of this standard. Annex B provides guidance on the

provisions of this standard.
For the purposes of this standard:

• “shall” means that compliance with a requirement is mandatory for compliance with this

standard;

• “should” means that compliance with a requirement is recommended but is not mandatory

for compliance with this standard;

• “may” is used to describe a permissible way to achieve compliance with a requirement;

• “establish” means to define, document, and implement; and

• where this standard uses the term “as appropriate” in conjunction with a required PROCESS,

ACTIVITY, TASK or output, the intention is that the MANUFACTURER shall use the PROCESS,

ACTIVITY, TASK or output unless the MANUFACTURER can document a justification for not so

doing.
---------------------- Page: 12 ----------------------
62304 © IEC:2006 – 9 –
62304  IEC:2006 – 17 –
MEDICAL DEVICE SOFTWARE –
SOFTWARE LIFE CYCLE PROCESSES
1 Scope
1.1 * Purpose

This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of

PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework

for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.
1.2 * Field of application

This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE.

This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when

software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final

MEDICAL DEVICE.
MEDICAL DEVICE, even when the
This standard does not cover validation and final release of the
MEDICAL DEVICE consists entirely of software.
1.3 Relationship to other standards

This MEDICAL DEVICE SOFTWARE life cycle standard is to be used together with other appropriate

standards when developing a MEDICAL DEVICE. Annex C shows the relationship between this

standard and other relevant standards.
1.4 Compliance

Compliance with this standard is defined as implementing all of the PROCESSES, ACTIVITIES, and

TASKS identified in this standard in accordance with the software safety class.

NOTE The software safety classes assigned to each requirement are identified in the normative text following the

requirement.

Compliance is determined by inspection of all documentation required by this standard

including the RISK MANAGEMENT FILE, and assessment of the PROCESSES, ACTIVITIES and TASKS

required for the software safety class. See Annex D.
NOTE 1 This assessment could be carried out by internal or external audit.

NOTE 2 Although the specified PROCESSES, ACTIVITIES, and TASKS are performed, flexibility exists in the methods

of implementing these PROCESSES and performing these ACTIVITIES and TASKS.

NOTE 3 Where any requirements contain “as appropriate” and were not performed, documentation for the

justification is necessary for this assessment.

NOTE 4 The term “conformance” is used in ISO/IEC 12207 where the term “compliance” is used in this standard.

---------------------- Page: 13 ----------------------
– 10 – 62304 © IEC:2006
62304  IEC:2006 – 19 –
2 * Normative references

The following referenced documents are indispensable for the application of this document. For

dated references, only the edition cited applies. For undated references, the latest edition of

the referenced document (including any amendments) applies.
ISO 14971, Medical devices – Application of risk management to medical devices.
3 * Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
ACTIVITY
a set of one or more interrelated or interacting TASKS
3.2
ANOMALY

any condition that deviates from the expected based on requirements specifications, design

documents, standards, etc. or from someone’s perceptions or experiences. ANOMALIES may be

found during, but not limited to, the review, test, analysis, compilation, or use of SOFTWARE

PRODUCTS or applicable documentation
[IEEE 1044:1993, definition 3.1]
3.3
ARCHITECTURE
organizational structure of a SYSTEM or component
[IEEE 610.12:1990]
3.4
CHANGE REQUEST
a documented specification of a change to be made to a SOFTWARE PRODUCT
3.5
CONFIGURATION ITEM
entity that can be uniquely identified at a given reference point
NOTE Based on ISO/IEC 12207:1995, definition 3.6.
3.6
DELIVERABLE
required result or output (includes documentation) of an ACTIVITY or TASK
3.7
EVALUATION

a systematic determination of the extent to which an entity meets its specified criteria

[ISO/IEC 12207:1995, definition 3.9]
---------------------- Page: 14 ----------------------
62304 © IEC:2006 – 11 –
62304  IEC:2006 – 21 –
3.8
HARM

physical injury, damage, or both to the health of people or damage to property or the

environment
[ISO/IEC Guide 51:1999, definition 3.3]
3.9
HAZARD
potential source of HARM
[ISO/IEC Guide 51:1999, definition 3.5]
3.10
MANUFACTURER

natural or legal person with responsibility for designing, manufacturing, packaging, or labelling

a MEDICAL DEVICE; assembling a SYSTEM; or adapting a MEDICAL DEVICE before it is placed on

the market and/or put into service, regardless of whether these operations are carried out by

that person or by a third party on that person’s behalf
[ISO 14971:2000, definition 2.6]
3.11
MEDICAL DEVICE

any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or

calibrator, 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

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 for medical purposes by means of in vitro examination of specimens

derived from the human body,

and which does not achieve its primary intended action in or on the human body by

pharmacological, immunological or metabolic means, but which may be assisted in its function

by such means

NOTE 1 This definition has been developed by the Global Harmonization Task Force (GHTF). See bibliographic

reference [15] (in ISO 13485:2003).
[ISO 13485:2003, definition 3.7]

NOTE 2 Some differences can occur in the definitions used in regulations of each country.

3.12
MEDICAL DEVICE SOFTWARE

SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the

MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE in its own right

3.13
PROBLEM REPORT

a record of actual or potential behaviour of a SOFTWARE PRODUCT that a user or other interested

person believes to be unsafe, inappropriate for the intended use o
...

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