Software CE Marking

EN ISO 62304:2006 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


Software CE Marking

Yes, Most of the class A device exempted from NB intervention.




  • INDIA – Bangalore
    + 91 994 591 2081
    Phone / WhatsApp


    USA – Chicago
    +1 630 696 1293
    Phone / WhatsApp


    GERMANY – Bremen
    +49 2161 990 8831
    Phone / WhatsApp


    mail enquiry@i3cglobal.com
    LiveZilla Live Chat Software