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 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. URS is UKAS accredited ISO 13485 Certification. Therefore, UKAS accredited ISO 13485 Certification are issued by URS. ISO Certified Company can use URS and UKAS logos or URS as per certification logo regulations.
Recognition of Certification for ISO 13485 Standard Certified Clients are registered on URS website and details shall be accessed through 'Client Zone' on URS website.
URS also issues ISO 13485+ ISO 9001 Combined Certificate accredited by UKAS.