IEC 62304 and Quality management system

Shortcuts: Differences, Similarities, Jaccard Similarity Coefficient, References.

Difference between IEC 62304 and Quality management system

IEC 62304 vs. Quality management system

The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.

Similarities between IEC 62304 and Quality management system

IEC 62304 and Quality management system have 4 things in common (in Unionpedia): ISO 13485, ISO 9000, Medical device, Regulatory compliance.

ISO 13485

ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

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ISO 9000

The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.

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Medical device

A medical device is any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of.

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Regulatory compliance

In general, compliance means conforming to a rule, such as a specification, policy, standard or law.

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The list above answers the following questions

What IEC 62304 and Quality management system have in common
What are the similarities between IEC 62304 and Quality management system

IEC 62304 and Quality management system Comparison

IEC 62304 has 20 relations, while Quality management system has 67. As they have in common 4, the Jaccard index is 4.60% = 4 / (20 + 67).

References

This article shows the relationship between IEC 62304 and Quality management system. To access each article from which the information was extracted, please visit:

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