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Medical device and Quality management system

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

Difference between Medical device and Quality management system

Medical device vs. Quality management system

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. A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.

Similarities between Medical device and Quality management system

Medical device and Quality management system have 10 things in common (in Unionpedia): Code of Federal Regulations, Design controls, Food and Drug Administration, Good manufacturing practice, International Organization for Standardization, ISO 13485, ISO 9000, Medical Devices Directive, Quality management, Regulatory compliance.

Code of Federal Regulations

The Code of Federal Regulations (CFR) is the codification of the general and permanent rules and regulations (sometimes called administrative law) published in the Federal Register by the executive departments and agencies of the federal government of the United States.

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Design controls

Design controls designates the application of a formal methodology to the conduct of product development activities.

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Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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Good manufacturing practice

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.

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International Organization for Standardization

The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from various national standards organizations.

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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 Devices Directive

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union.

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Quality management

Quality management ensures that an organization, product or service is consistent.

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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

Medical device and Quality management system Comparison

Medical device has 80 relations, while Quality management system has 67. As they have in common 10, the Jaccard index is 6.80% = 10 / (80 + 67).

References

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

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