IEC 62304 / ISO 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.
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. Still, it does not require an organization to be certified in ISO 13485.
Standalone Software CE Marking and ISO 62304
ISO 62304 MANDATORY PROCEDURE
|
No |
CL# |
Procedure Name |
Requirement |
Class |
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|---|---|---|---|---|---|---|
| 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 *
|
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| 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 *
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||
| 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 |
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 |
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02 |
4.1.6 |
Validation of the application of software used in QMS |
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03 |
4.2.4 |
Control of Documents |
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04 |
4.2.5 |
Control of Records |
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05 |
5.6 |
Management Review |
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06 |
6.2 |
Human Resources |
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07 |
6.3 |
Infrastructure |
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08 |
6.3 |
Maintenance Activities |
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09 |
6.4.1 |
Control of Work Environment |
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10 |
6.4.1 a |
Health, Cleanliness and Clothing |
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11 |
6.4.2 |
Control of Contaminated or Potentially Contaminated Product |
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12 |
6.4.2 |
Contamination Control for Sterile Medical Devices |
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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 |
|||
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5.3 |
Software architectural design |
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5.4 |
Software detailed design |
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5.5 |
Software unit implementation and verification |
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5.6 |
Software integration and integration testing |
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6 |
Software maintenance process |
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6.3 |
Modification implementation |
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|
15 |
7.3.7 |
Clinical Evaluation |
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16 |
7.3.8 |
Design & Development Transfer |
5.8 |
Software Release |
|
17 |
7.3.9 |
Design & Development Changes |
6.2.3 |
Analyse change requests |
|
5.7.1 |
Establish tests for software requirements |
|||
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5.7.3 |
Retest after changes |
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|
18 |
7.4 |
Purchase Process |
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19 |
7.5.2 |
Cleanliness of the Product |
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20 |
7.5.3 |
Installation and Acceptance Criteria |
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21 |
7.5.4 |
Servicing Activities |
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22 |
7.5.6 |
Validation of processes for production and service provision |
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23 |
7.5.6 |
Validation of the software used in production. |
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24 |
7.5.7 |
Validation of processes for sterilization and sterile barrier systems |
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25 |
7.5.8 |
Product Identification |
8 |
Software configuration management process |
|
26 |
7.5.8 |
Identification of returned medical device |
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|
27 |
7.5.9 |
Traceability |
8 |
Software configuration management process |
|
28 |
7.5.11 |
Product Preservation |
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|
29 |
7.6 |
Monitoring and measuring |
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|
30 |
7.6 |
Calibration |
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31 |
7.6 |
Validation of Software used for Monitoring and Measurement |
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32 |
8.2.1 |
Feedback process |
6.2 |
Problem and modification analysis |
|
33 |
8.2.1 |
Post Market Surveillance |
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34 |
8.2.1 |
Post Market Clinical Follow up |
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35 |
8.2.2 |
Handling of Customer Complaints |
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|
36 |
8.2.3 |
Notifying the regulatory authorities |
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|
37 |
8.2.4 |
Internal audit |
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|
38 |
8.2.6 |
Monitoring & Measurement of Product |
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|
39 |
8.3 |
Nonconforming product |
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|
40 |
8.3.3 |
Advisory Notice |
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|
41 |
8.3.4 |
Rework |
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|
42 |
8.4 |
Analysis of Data |
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|
43 |
8.5.2 |
Corrective and Preventive Action |
9 |
Software Problem Resolution Process |