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ISO 13485:2016 Preview Medical devices -- Quality management systems
Nov 18, 2017

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. E-mail: muletech@mocular.com

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls. http://www.mocular.net

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

Mocular Medical always feel that all success of our company is directly related to the quality of the products we offer. They meet the high quality requirements as stipulated in ISO13485 CE guidelines and our stringent quality control system.  http://www.mocular.net
A general optical adapter and interface" won the people's Republic of China State Intellectual Property Office issued a patent certificate of utility model
R & D" operation microscope video system"," head Lok HD camera system, operation"" head Lok slit lamp image processing system software"," Le Department of Ophthalmology eye image processing software" was awarded the people's Republic of China Copyright Bureau issued the software copyright.

Mocular Medical was established in 2005, is a set of medical investment, medical management, the new digital equipment research and development, production in a body comprehensive enterprise. In recent years, in response to the" Ministry of science and technology puts forward the industrialization of research results." We organized a group of electronic, mechanical, optical, computer aspects of senior experts and professors, will have formed independent intellectual property rights of scientific research more widely applied to the old instrument upgrades and new digital medical equipment development.

E-mail: muletech@mocular.com







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