ISO 13485: 2003 sets the requirements for manufactures of medical devices

ISO 13485 focus on risk, regulatory and legal requirements by eliminating emphasis on continual improvement and customer satisfaction; ISO 13485 is a stand alone certifiable management system tha focus in fulfilling legal and regulatory requirements. 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 . Contact us to see how we can help.

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, Grifol's and Kapprel. 

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.

Download brochure (CMDCAS, FDA, MDD...)