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MARKED CE MEDICAL DEVICES OR MEDICAL DEVICE
The implementation of a system of management based on the family of standards ISO and its rear certification are undoubtedly actions that lead to a company to differentiate is of the rest and take advantage in the market, Since it is shown that the management of the company follows a quality standards.
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What is a medical product?
A medical device is any instrument, device, team, program computer, material or other article, used alone or in combination, including computer programmes by the manufacturer for specific purposes of diagnosis and/or therapy that involved in the functioning, intended by the manufacturer to be used for human beings.
Are considered products for diagnosis in vitro any health product which consists in:
- A reagent, reagent product.
- Gauge.
- Control material.
- Case of instrumental and material.
- Instrument, appliance, equipment or system.
License of functioning of the installations of sanitary products.
- Identification of policy and State law applied to the product.
- Consulting for the in-vitro medical or health product classification and the choice of the module of conformity assessment.
- Preparation of the technical documentation required by the directive (s) applying.
- Preparation of the dossier technical for obtaining of the certification CE and/or declaration CE of conformity and management with agencies notified.
- Consulting and management of laboratory trials necessary for certification.
Do we offer?
Technical assistance periodic by one of our experts, University graduates admitted by the Directorate General of Pharmacy and health products of the Ministry of health to provide the service of technical manager for the marketing of health and cosmetic products.
In addition to in-company training, in order to train its technical manager.
A integral service to get your quality management system for medical devices:
- Takes data and issuing initial assessment report.
- design of quality and specific procedures manuals.
- Definition of a planning of dates with objective certification.
- Implementation of procedures: Conference training and information.
- Internal audit.
- Support in the certification audit by auditors chosen entity.
- Annual maintenance of the implanted system.
- Permanent online consulting.
