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From Wikipedia, the free encyclopedia. This standard is partially in line with ISO 14388 A very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product s. InThe Farmacopea de los Estados Unidos Mexicanos United Mexican States Pharmacopoeiamedical industrial sectors and Cofepris are working together for updating NOM Standard, putting special attention on manage of risks during manufacture and regulating by manufacturing lines some of the most important medical devices manufacturing processes.
Accept and continue Learn more about the cookies we use and how to change your settings. You may find similar items within these categories by selecting from the choices below:. This International Standard specifies, in conjunction with ISOthe quality system requirements for the production and, when relevant, installation and servicing of medical devices. Click to learn more. A principal difference, however, is that ISO requires the organization to demonstrate continual improvementwhereas ISO requires only that the certified organization demonstrate the quality system is 134888 implemented and maintained.
BS EN ISO 13488:2001
Please download Chrome or Firefox or view our browser tips. Medical device, to the substance, mixture of substances, material, apparatus or instrument including the computer program necessary for its proper use 1488 applicationused alone or in combination in ido diagnosis, monitoring or prevention of human or auxiliary diseases in the treatment of the same and of the disability, as well as the employees in the replacement, correction, restoration or modification of the anatomy or human physiological processes.
This Standard includes the following cross references: Mexico has published in October 11, a national standard as a Norma Oficial Mexicana NOM to control manufacture of medical devices inside the country. This website is best viewed with browser version of up to Microsoft Internet Explorer 8 or Firefox 3.
The faster, easier way to work with standards. ISO Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization ISO standard published for the first time in ; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Learn more about the cookies we use and how to change your settings.
Abstract This International Standard specifies, in conjunction with ISOthe quality system requirements for the production and, when relevant, installation and servicing of medical devices. This standard embraces all the principles of good manufacturing practice GMP widely used in the manufacture of medical devices. The Cofepris is the body assigned to its control, verification and to grant the records of compliance to the companies that implement this Standard of Good Manufacturing Practices. This International Standard, in conjunction with ISOis applicable when there is a need to assess a medical device supplier's quality system.
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For those medical devices requiring the pre-market involvement of a Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and 1488 permission to sell the medical device in the European Union. Retrieved 19 October Take the smart route to manage medical device compliance.
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Medical equipment, Quality assurance, Quality control, Quality assurance systems, Medical instruments, Quality auditing. Find Similar Items This product falls into the following categories. Additionally, the ISO requirements regarding customer satisfaction are absent from the medical device standard.
Company organization, management and quality.
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ixo Your basket is empty. The current ISO effective edition was published on 1 March Medical devices include products of the following categories: ISO standards by standard number. Retrieved from " https: