Risk management

A critical step in the development and manufacturing of medical devices is a proper risk management process to ensure the safety of the product. EN-ISO 14971:2009 addresses the requirements and methods of risk management and is a harmonized standard in order to ensure compliance with the medical device directive. Understanding the conditions for a successful implementation of the risk management process becomes a key prerequisite for fulfillment of the requirements.

A well-functioning risk management process extends cross-business and captures the risk in the situation where it is identified. It is important to identify each specific input to the risk management process and to manage it effectively. Designated functions within the organization must accept the risk only if the benefit succeeds the risk. It is the management’s responsibility to decide whether the risk management process is functioning as intended. To achieve this, the communication and documentation within the company must function properly.

Our consultants have extensive experience in practical application of risk management. We arrange courses within the field of risk management, at SIS Forum (Swedish Standards Institute) or customized trainings in-house, all depending on your requests.

With can provide you with support regarding:

• Development of product-specific documentation indicating compliance with safety requirements
• Implementation of efficient methods for risk management
• Business- or product specific training in risk management