Software CE Marking

ISO 13485 Integration with ISO 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


Software CE Marking

No. ISO 13485 Quality Manual must address the respective requirments wherever applicable. An Integrated Quality Manual is most preffered.




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