ISO 13485:2016 Standard Section 7 – Product realization »
Review of the ISO 13485:2016 Standard requirements for section 7 – Product realization
7.3.7 Design and development validation – Objectives
Did you design the right Medical Device? This is the main question that design and development validation needs to answer. design validation refers to the sum of all efforts necessary to ensure that the
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Challenges manufacturers of medical devices are facing when implementing labels under the ISO 13485
Labeling refers to the identification of the medical device during its lifecycle. Labeling the medical device is a challenging task for manufacturers in an ever-complicated environment. And the activity of printing and assembling the
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The challenges of Computer Systems Validation (CSV)
The Computer Systems Validation (CSV) is requested by the ISO 13485 in clause 7.5.6 – Validation of processes for production and service provision. The requirement: The organization shall document procedures for the validation of the application
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ISO 13485:2016 Standard – 7.5.8 Identification
The ISO 13485 Standard demands the organization establish and maintain a systematic identification of its business activities and process results throughout the material flow. The identification shall be according to specifications: medical device specifications
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ISO 13485:2016 Standard – 7.5.6 Validation of processes for production and service provision
Process validation is next control required by the ISO 13485 Standard, and an effective process validation contributes significantly to ensuring the quality of the medical device. Validation means testing that expected results and objectives
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ISO 13485:2016 Standard – 7.5.1 Control of production and service provision
The organization is required to perform the realization of the product and the provision of the service under controlled conditions. The control must be performed and achieved according to the planning requirements specified within
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ISO 13485:2016 Standard – 7.1 – Planning and documenting risk management activities
The organization is required to define, plan, establish, document, and maintain one or more processes for risk management activities that will cover the entire realization processes of the medical device and refer to all
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