Providers & Products

We have manufacturers, suppliers and service providers from the area QMS software validation according to EN ISO 13485

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Localisation of Medical Software
Transline Gruppe GmbH
EN ISO 13485 web documentation
Squadhouse Media GmbH & Co. KG

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QMS software validation

QMS software validation

EN ISO 13485 QMS software validation requires an organization to have documented procedures for the verification of computer software used in the manufacturing and quality management systems. The scope of the validation is broader than the US requirements, but the draft of the standard still includes the software validation requirement. The FDA requires this for products that are intended for human use. Once a product is distributed, the organization should develop a risk-based quality plan to ensure compliance with the new standards.

The validity of software for the purpose of a Quality Management System is an important component of the overall system. This is true for medical device manufacturers as computers are used extensively during the entire product life cycle. This includes traceability, complaint management, service, disposal, and more. To achieve these goals, the software must be validated for its intended use. However, this is a complex process that requires the involvement of an expert.

The software for medical devices must be validated for their intended use. The purpose of the validation depends on the purpose of the device, and the intended users of the software. Throughout the lifecycle of a medical device, computers are used extensively. This means that the software must be validated for the purposes of traceability, complaint management, service, and disposal. In addition to validation for the intended uses, a medical device manufacturer must also validate its software for regulatory requirements.

The requirements of EN ISO 13485 are universal and apply to all organizations involved in the lifecycle of a medical device. If you're looking for software to help your organization achieve ISO 13385:2016 compliance, GitLab can help. This software contains many features and controls, but can't guarantee compliance. Whether you're looking for an online or offline validation solution, GitLab has the tools and resources to support you.

Despite the importance of a good quality management system, the validation of software for medical devices can be time-consuming and difficult. The validation of an eQMS is not an easy task. The software must be aligned with EN ISO 13485 requirements, and it must be compatible with the corresponding eQMS tools. To ensure compliance, a company must also validate the software with the EN ISO 13685 certification body.

The software should help the manufacturer to validate their medical device. Its built-in workflows and issue recording forms are designed to help companies improve their quality management. By establishing a quality management system, manufacturers can demonstrate their compliance with EN ISO 13485. Using a QMS software is an essential part of this certification process. The software should also be able to meet the requirements of the standard.

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