ISO 13485: 2016 sets the requirements for manufactures of medical devices, with emphasis in regulatory purpose
Current ISO 13485 focus on risk, regulatory and legal requirements; ISO 13485 is a stand alone management system with the
purpose to contribute in fulfillment of regulatory requirements and legal obligations. QMSMDD ISO 13485 remains attune to ISO 9001:2008 not to the 2015 version, and 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 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. The use of ISO 14971 provides guidance
to assess risk for medical devices. For additional information on ISO 13485 visit IMDFR.COM.
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.
Transition to the 2016 version ISO 13485 is require in 2019 first assessment, a three (3)
years elapse from its publication in March of 2016.
Why BRS and ISO 13485
- BRS carries the consumer - centric GOB | GCC Platform mark.
- Our emphasis is on regulations such as MOH, GPDMD and regulatory free market others.
- We are a certification body with an innovative approach to benefit client organizations and consumers.
- 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 and the medical devices consumer protection supply chain.
- Our assessment teams are uniquely certified professionals conducting BRS assessments; we do not subcontract
certification professionals to work in behalf of BRS, so mission and values are consistently with Due Care.
- We focus on protection of client-organizations, consumers, and how a management system such as ISO 13485 contributes to the benefit of business objectives.
The latest revision of ISO 13485, 2016, update with newer European requirements.
The key changes to the 2016 version include:
- Inclusion of risk considerations beyond product realization, and within the context of the safety and performance of the medical device in addressing regulatory requirements
- Continuing "...for regulatory purpose" includes explicit documentation.
- The product's life cycle and relational supply chain for medical devices is now inclusive.
- In matters of software, validation ties in per and for applications whether is: process control, monitoring, measurement and for QMS.
- Appropriateness of the organization's infrastructure and now considering for sterile medical devices with validation of sterile barrier properties.
- Design and development considers usability, applicability of regulations, and activities of planning verification and validation, design transfer, design records and design changes.
- Complaint handling and reporting to regulatory authorities in compliance to regulations while considering post-market surveillance work.
- Taking corrective action promptly and bearing preventive action (risk consideration).
It is our duty to understand client-organization's management practices and methods attune to the contractual agreement management system.