ISO 13485
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What is ISO 13485 : 2016 ?
   
     ISO 13485 is a Quality System for Medical Device and adopt a risk 
management approach to identify risk throughout the medical device 
product realization and such identified risks are managed to eliminate 
hazardous situations in medical device.
    The ISO13485 certification for Medical Device is valid for 3 years. The 
company can renew the certificate after 3 years.
    Though it is an international certification for Medical devices, however, 
the country can modify the regulations as per their business 
requirements. 
Type of companies for ISO 13485 certification for Medical Device
 It has become mandatory for all the Medical device businesses to 
obtain the ISO 13485 certification for Medical Device so that they 
work as per the Quality Management system standards. Some of 
the medical device businesses are:
       Medical devices producing corporations
       Subcontractors
       Medical device installing firms
       Consultation Groups
       Warehouses and other storehouses
       Companies providing maintenance
       Medical representatives
       Distribution Centres
UKAS Accredited ISO 13485 certification provides following 
Benefits:
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
Certificate issued by URS are accepted world over
Why Choose US ?
 Member of URS Holdings,
 Multiple International Accreditations,
 Ecumenical presence - offices in 50 World Hubs having regional offices 
in more than 150 Countries/States with Lacs of Certified locations in 
the world covering USA, Europe, UK, Asia, Middle East and Russia,
 IAF member recognition by Multi-lateral Recognition Agreement 
(MLA) ensures certification by URS as an Accredited Registrar is 
accepted throughout the macrocosm,
 Is among the Top Five CBs of the world (QSU magazine report).
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