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High-Tech Medical Device production demands a valid Quality System
Cenova is working with development and manufacturing of products within the Medical and Medical Device area. To be allowed to develop and manufacture products within this area, Cenova must present a valid quality system that conforms with SS-EN ISO 9001:2008 and
SS-EN ISO 14001, and for some customers also SS-EN ISO 13485.
Cenova has also implemented applicable requirements from directive 93/42/EEC and 21CFR Part 820.
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The development, production and quality assurance systems are certified and conforms with those demands, wich enables Cenova to help the customer to put the CE-mark on developed and produced Medical Devices.
The certification has been performed by DNV, Det Norske Veritas, with certificate No: 2000-SKM-AQ-1513 and Notified Body No:0434.
Cenova´s Quality Policy
Definition of quality:
The quality of a product or service is it´s ability to at all occasions fulfil or preferably exceed the customers needs and demands as well as his expectations.
Cenova shall on customers request, develop and manufacture products within the area Medical Devices and Packaging Systems in plastics, produced in Cleanrooms, where the products and/or services shall be delivered in time and with the highest possible quality, with the vision to reach zero-defects.
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