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.

ISO 13485 Standard  clauses and requirement are applicable to all types of organizations irrespective of size or nature and applicable to all like Hospital, Health Care, Trading, Manufacturing, Service Companies, Software, Construction, Medical Devices in India. URS offers 

ISO 13485 Certification 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.

Adoption of ISO 13485 Standard requirements  by Medical Device Manufacture also reduces trade barrier to enter into international market such as Europen Market. This Certification is voluntary, even, adopting and obtaining ISO 13485 certification allows medical device manufacturer to meet Quality System requirement of European Medical Device Directives such as EU directive 93/42/EEC and  in Vitro Medical Device Directive 98/79/EC, Active Implantable Medical Device Directive 90/835/EEC.

Benefits of 13485 certification:

• Guarantees high quality of provided services and products
• Reduces production loss rate
• Reduces operational costs and reduces risk
• Increases effectiveness across the whole organisation
• Increases your customers‘ trust in you as a safe supplier or producer