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DNS BUSINESS ASSURANCE MANAGEMENT SYSTEM CERTIFICATE No. 110714-2012-AQ-SWE-NA This is to certify that the Management System of: Ascot (Sweden) AB G?TENOR and HERRLJUNGA, Sweden has been found to

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What is iso 13485 - ascom?

ISO 13485 - Ascom is a standard for medical device manufacturers, specifying requirements for a quality management system.

Who is required to file iso 13485 - ascom?

Medical device manufacturers who intend to export their products to certain countries or seek regulatory approval may be required to file ISO 13485 - Ascom.

How to fill out iso 13485 - ascom?

To fill out ISO 13485 - Ascom, companies need to establish and document a quality management system that complies with the standard's requirements. This includes implementing processes, procedures, and documentation to address various aspects of the system.

What is the purpose of iso 13485 - ascom?

The purpose of ISO 13485 - Ascom is to ensure that medical device manufacturers have an effective quality management system in place. This helps to ensure the safety and efficacy of medical devices and promotes regulatory compliance.

What information must be reported on iso 13485 - ascom?

ISO 13485 - Ascom requires reporting of information related to the quality management system, including processes, procedures, documentation, and records. It also requires reporting on any nonconformities, corrective actions, and preventive measures taken.

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