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IEC 62304 Procedures

Compliance with IEC 62304 is a mandatory requirement for US FDA during 510k submission and the European Union’s Notified Bodies, as part of EU MDR CE Marking and IVDR technical documentation file submission.

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 based on a medical device quality management system platform such as ISO 13485 OR 21 CFR 820 or FDA QMSR.

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

With the help of ISO consultants such as I3CGlobal, the developers can identify, prepare, modify, implement, and conduct regular reviews and updates to these procedures to ensure ongoing compliance and effectiveness in managing software development activities.

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List of IEC 62304 Procedures

IEC 62304 aims to standardize the software development lifecycle (SDLC) processes specifically tailored for medical device software (firmware and standalone software). It establishes a set of requirements that help organizations manage the complexities and risks associated with medical software development, ensuring that the final product meets necessary safety and performance criteria.

The below list provides procedure requirements against each class.

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

Frequently Asked Questions

What is the timeline for IEC 62304 Implementation??

Generally it takes 3-4 months

Is IEC 62304 mandatory for an FDA 510(k) submission?

While IEC 62304 is not mandatory for FDA 510(k) submission, it is a recognized consensus standard that must be followed in fulfilling FDA requirements for software as a medical device (SAMD).