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IEC 62304 4 min

IEC 62304 Procedures - An Introduction

IEC 62304 is an international standard that specifies requirements for the life cycle processes of medical device software. It provides guidance for the development, maintenance, and risk management of software used in medical devices. The standard applies to the entire software life cycle, including software development, verification, validation, and maintenance processes. It covers software used in medical devices, including embedded software, firmware, and software that is part of a medical device / standalone software (SAMd).

IEC 62304 Procedures - Why?

Compliance with IEC 62304 is a mandatory requirment by regulatory authorities, such as the US FDA during 510k submission and the European Union’s Notified Bodies, as part of EU MDR CE Marking technical documentation file submission. Adherence to the standard helps ensure that software medical devices are developed and maintained in a manner that assures patient safety and regulatory compliance

 

Developing procedures compliant with IEC 62304 requires a systematic approach to software development, verification, validation, and maintenance.  These procedures should be prepared to the specific needs and context of your organization and should be documented, implemented, and maintained in accordance with the requirements of IEC 62304 and based on a medical device quality management system platform such as ISO 13485 or 21 CFR 820 or FDA QMSR. Withe the help of consultants such as I3CGlobal, the developers can identify, prepare, modify, implement, conduct regular reviews and updates to these procedures to ensure ongoing compliance and effectiveness in managing software development activities.

 

Here’s a general outline of procedures you might consider implementing:

List of IEC 62304 Procedures

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