ISO 14971 is an international risk management standard for medical devices (including in vitro diagnostic medical devices) and is widely recognized in many geographies – Regulators in most major markets expect medical device manufacturers to use this standard to manage risk.
We can help you to:

• Establish Risk Management Procedures according to ISO 14971
• Establish Risk Management Files
• Incorporate ISO 13485 in the design and development process
• Closing the loop to production and post-production information
• Integration of Risk Management into the Quality Management System

Risk management is a process for identifying, evaluating and mitigating risk. For medical devices, this means product safety, including risks associated with harm to people and damage to property or the environment. Risk management has become an integral part of medical device design and development, production processes and evaluation of field experience. We provide support in

• Development of risk management policy and risk management plans
• Moderate risk analysis meetings
• Conduction of Risk Assessment
• Review of Risk Management Files

We provide training to your organization (group session or individual coaching of your staff) on:

• Risk Management Process
• Methodologies, such as Failure Mode and Effects Analysis FMEA or Fault Tree 1:1048576 FTA

ISO/IEC 62366 is a process-based standard that aims to help manufacturers of medical devices 'design in' usability and 'design out' usage errors. The standard also applies to documentation that may accompany a device, and to the training of intended users.
We can help you to:

• Establish Usability Engineering Procedures according to EN 62366 and integrate them with your existing 'design and development' and 'risk management' procedures
• Establish Usability Engineering Files