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    Software CE Marking

    IEC 62304

    IEC 62304:2006/Amd 1:2015 is the latest standard for Medical device Software life cycle processes. The standard defines the lifecycle requirements covering the set of processes, activities, and tasks for medical device software.

    Clinical Evaluation Report

    IEC 62304 & ISO 13485 Relationship

    IEC 62304 must be applied in conjunction with ISO 13485 standard which offers a framework for the lifecycle processes necessary for the safe design, risk analysis, version control and maintenance of standalone software.

    As a basic foundation, IEC 62304 assumes the guiding principles for the development of and maintenance within a QMS such as ISO 13485 but does not require an organization to be certified in ISO 13485.

    Standalone Software CE Marking and ISO 62304

    IEC 62304 Certification
    Standalone software manufacturers interested in CE marking of their devices have to follow all applicable harmonized standards. EN 62304:2006 is one of the applicable standards for software.
    Safety and performance are the 2 major concerns for all medical standalone software used across the globe.
    Device regulatory approvals such as CE marking and/or FDA 510k clearance are essential to gain access to regulated markets and customer confidence.

    ISO 62304 MANDATORY PROCEDURE

    No

    CL#

    Procedure Name

    Requirement

    Class

    1

    5.1

    Software Development Planning

    The MANUFACTURER shall establish a software development plan (or plans) for conducting the ACTIVITIES of the software development PROCESS appropriate to the scope, magnitude, and software safety classifications of the SOFTWARE SYSTEM to be developed.

    A+B+C

    *
    2

    5.2

    Software Requirements Analysis

    For each SOFTWARE SYSTEM of the MEDICAL DEVICE, the MANUFACTURER shall define and document SOFTWARE SYSTEM requirements from the SYSTEM level requirements.

    A+B+C

    3

    5.3

    Software Architectural Design

    Transform software requirements into an ARCHITECTURE
    Develop an ARCHITECTURE for the interfaces of SOFTWARE ITEMS
    Specify functional and performance requirements of SOUP item
    Specify SYSTEM hardware and software required by SOUP item
    Identify segregation necessary for RISK CONTROL
    Verify software ARCHITECTURE

    B+C

    *
    4

    5.4

    Software Detailed Design

    The MANUFACTURER shall refine the software ARCHITECTURE
    The MANUFACTURER shall develop and document a detailed design
    Develop detailed design for interfaces
    Verify detailed design
     

    B+C

    ***

    5

    5.5

    Verification of Software Unit

    The MANUFACTURER shall establish strategies, methods and procedures for verifying each SOFTWARE UNIT.

    A+B+C

    ****

    6

    5.6

    Verification & Testin of Integrated Software

    The MANUFACTURER shall verify and record the following aspects of the software integration
    The MANUFACTURER shall test the integrated SOFTWARE ITEMS in accordance with the integration plan
     

    B+C
    7

    5.7.1

    Establishing  tests for software System Testing

    The MANUFACTURER shall establish and perform a set of tests, expressed as input stimuli, expected outcomes, pass/fail criteria and procedures, for conducting SOFTWARE SYSTEM testing, such that all software requirements are covered.
    B+C
    8

    5.7.3

    Retest after changes

    When changes are made during SOFTWARE SYSTEM testing, the MANUFACTURER
    B+C
    9

    5.8

    Software Release

    The MANUFACTURER shall ensure that all ACTIVITIES and TASKS are complete along with all the associated documentation.

    A+B+C

    *****

    10

    6.1

    Establishing Software Maintenance Plan

    The MANUFACTURER shall establish a software maintenance plan (or plans) for conducting the ACTIVITIES and TASKS of the maintenance PROCESS
    A+B+C
    11

    6.2.1

    Feed Back

    The MANUFACTURER shall monitor feedback on released SOFTWARE PRODUCT from both inside its own organization and from users.
    A+B+C
    12

    6.2.3
    6.2.4
    6.2.5

    Analysis, Approval of Change Requests & Communication of Changes

    Analyse CHANGE REQUESTS
    CHANGE REQUEST approval
    Communicate to users and regulators
     

    A+B+C

    ******

    13

    6.5

    Implementation of Approved Modifications

    The MANUFACTURER shall use the software development PROCESS (see Clause ___H5) or an established maintenance PROCESS to implement the modifications.
    A+B+C
    14

    7

    Risk Management Process

    (All Clauses). The same will be done as a part of ISO 13485

    A+B+C

    *******

    15

    8

    Configuration Management

    The MANUFACTURER shall establish a scheme for the unique identification of CONFIGURATION ITEMS and their VERSIONS to be controlled for the project.
    A+B+C
    16

    9

    Software Problem Resolution

    Prepare PROBLEM REPORTS
    Investigate the problem
    Advise relevant parties
    Use change control process
    Maintain records
    Analyse problems for trends
    Verify software problem resolution
    Test documentation contents
     

    A+B+C

    Note :-

    * Clause 5.1.4 is applicable only for Class C and 5.1.5, 5.1.10 & 5.1.11 applicable only for Class B & C

    ** Clause 5.3.5 is applicable only for Class C

    *** Clause 5.4.2, 5.4.3 & 5.4.4 are applicable only for Class C

    **** Clause 5.5.2, 5.5.3 & 5.5.5 applicable only for Class B & C and 5.5.4 applicable only for Class C

    ***** Clause 5.8.1, 5.8.2, 5.8.3, 5.8.5, 5.8.6, 5.8.7 & 5.8.8 are applicable only for Class B & C

    ****** Clause 6.2.3 is applicable only for Class B & C

    ******* Clause applicable for Class A in Sec 7 is 7.4.1

    ISO 13485 INTEGRATION WITH 62304

    List of Mandatory Procedures

    Sl.No

    Cl. 13485

    Title of the Procedure

    Cl. 62304

    Title of the Procedure

    01

    4.1.5

    Outsourced Process

    02

    4.1.6

    Validation of the application of software used in QMS

    03

    4.2.4

    Control of Documents

    04

    4.2.5

    Control of Records

    05

    5.6

    Management Review

    06

    6.2

    Human Resources

    07

    6.3

    Infrastructure

    08

    6.3

    Maintenance Activities

    09

    6.4.1

    Control of  Work Environment

    10

    6.4.1 a

    Health, Cleanliness and Clothing

    11

    6.4.2

    Control of Contaminated or Potentially Contaminated Product

    12

    6.4.2

    Contamination Control for Sterile Medical Devices

    13

    7.1

    Risk Management

    7

    Software Risk management process

    14

    7.3

    Design and Development

    5.1

    Software Development Planning

    5.2

    Software requirements analysis

    5.3

    Software architectural design

    5.4

    Software detailed design

    5.5

    Software unit implementation and verification

    5.6

    Software integration and integration testing

    6

    Software maintenance process

    6.3

    Modification implementation

    15

    7.3.7

    Clinical Evaluation

    16

    7.3.8

    Design & Development Transfer

    5.8

    Software Release

    17

    7.3.9

    Design & Development Changes

    6.2.3
    6.2.4
    6.2.5

    Analyse change requests
    Change request approval
    Communicate to users and regulators

    5.7.1

    Establish tests for software requirements

    5.7.3

    Retest after changes

    18

    7.4

    Purchase Process

    19

    7.5.2

    Cleanliness of the Product

    20

    7.5.3

    Installation and Acceptance Criteria

    21

    7.5.4

    Servicing Activities

    22

    7.5.6

    Validation of processes for production and service provision

    23

    7.5.6

    Validation of the software used in production.

    24

    7.5.7

    Validation of processes for sterilization and sterile barrier systems

    25

    7.5.8

    Product Identification

    8

    Software configuration management process

    26

    7.5.8

    Identification of returned medical device

    27

    7.5.9

    Traceability

    8

    Software configuration management process

    28

    7.5.11

    Product Preservation

    29

    7.6

    Monitoring and measuring

    30

    7.6

    Calibration

    31

    7.6

    Validation of Software used for Monitoring and Measurement

    32

    8.2.1

    Feedback process

    6.2

    Problem and modification analysis

    33

    8.2.1

    Post Market Surveillance

    34

    8.2.1

    Post Market Clinical Follow up

    35

    8.2.2

    Handling of Customer Complaints

    36

    8.2.3

    Notifying the regulatory authorities

    37

    8.2.4

    Internal audit

    38

    8.2.6

    Monitoring & Measurement of Product

    39

    8.3

    Nonconforming product

    40

    8.3.3

     Advisory Notice

    41

    8.3.4

    Rework

    42

    8.4

    Analysis of Data

    43

    8.5.2

    Corrective and Preventive Action

    9

    Software Problem Resolution Process