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ISO 13485: 2003 sets the requirements for manufactures of medical devices ISO 13485 focus on risk, regulatory and legal requirements by eliminating ISO 9001 emphasis on continual improvement and customer satisfaction; ISO 13485 is a stand alone certifiable
management system. ISO 13485 is an excellent match for FDA cGMP QSR (21 CFR Part 820 and CDRH Data Base
) and other equivalent requirements worldwide. ISO 13485 provides a means for organizations in the supply-chain of medical devices to manage regulatory and legal
requirements including interaction with HIPAA and Sarbanes-Oxley as well
European Union MDD. 
ISO 13485 requires that risk management be documented and conducted throughout a product's life cycle, from conceptual to usage. ISO 14971 provides guidance to assess risk for medical devices. For additional
information on ISO 13485 visit the GHTF
.
At BRS we take the approach that certification to ISO 13485 is to provide an impartial evidence of competence in managing regulatory and legal requirements to point-of-origin and point-of-sales. Our professional experience
derives from working with major medical corporations such as GEMS, Kimberly-Clark Professional Health Care, ITL, and Grifol's. Why BRS and ISO 13485
- BRS carries GOB | GCC Accreditation Platform mark.
- We are newly created certification body taking innovative approach to benefit client organizations.
- We focus in consumer protection, and we are not trying to be everything to everyone.
- Our base of clients is small and our vision is to keep it manageable so as to benefit client-organizations.
- Our assessment teams are uniquely certified professionals conducting BRS assessments; as we do not subcontract certification professionals to work in behalf of BRS, so mission and values are consistent.
- We focus on protection of client-organizations, consumers, and how a management system such as ISO 13485 contributes to the benefit of business objectives.
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