ISO 14971 Risk Management Certification
Looking for ISO 14971 Risk Management certification? Core Compliance can guide your medical device organization to compliance within your timeline and budget. ISO 14971 is a developed management system for medical device manufacturers to identify the defects or hazards associated with medical devices, including in vitro diagnostic medical devices, to evaluate & estimate the associated risks, and control these risks, and to monitor the effectiveness of the controls.
ISO 14971 Regulatory Compliance Process
ISO 14971 Regulatory compliance process– focuses on the application of risk management to medical devices. Requiring the Implementation of management policies, procedures and practices. Core Compliance define the risk management process, that includes a framework of requirements and road map to compliance that includes:
- Establish Framework
- Establish Intended Use
- Identify Hazards
- Define the Hazards
- Estimate Risk
- Evaluate the identified Risks (Develop Matrix chart)
- Risk Control
- Risk management report
- Product & Post Production
ISO 14971:2007 Revision
ISO 14971:2007 revision next addition ISO 14791:2012 (EN European) is currently in process- See ISO update which will have impact on the medical device industry related updates for risk management.
Our medical device consultants set a clear road map to certification. We review your current management system, processes and procedures and other manufacturing documentation, to ensure regulatory compliance.
- Gap Analysis
- Establish Risk Management process and Risk Management File
- Design and document a system for managing and evaluating risk that meets the requirements for ISO 14971
ISO Standards
