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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