ISO 13485 For Medical Device

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Presentation Description

ISO 13485 is the international quality standard stating the needs of Quality Management System for manufacturing and designing the Medical Devices across the globe.


Presentation Transcript


ISO 13485 CERTIFICATION Quality System for Medical Device 

ISO 13485 - Quality Management System:

ISO 13485 - Quality Management System ISO 13485 Standard requirement not only addresses the regulatory requirements applicable for medical device realization but also for device specific and customer specific requirement that have potential adverse impact and risk on the product. Organization who wish to adopt ISO 13485 standard , the clause of the standard clearly define and require how the ISO 13485 regulatory and customer specific requirements are addressed.

Benefits of 13485 certification::

Benefits of 13485 certification: Guarantees High Quality Of Provided Services And Products Reduces Production Loss Rate Reduces Operational Costs Increases Effectiveness Across The Whole Organisation Increases Your Customers‘ Trust In You As A Safe Supplier Or Producer


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