PROSYSTEM implements a risk management process according to ISO 14971 in your organization and supports your employees during the risk analysis.

Risk management is an essential part during product development, but also during production and post production. ISO 14971:2007 describes the requirements for risk management during all phases of the product life cycle. PROSYSTEM is a continuous member of theinternational standardization commitee and can therefore provide the newest trends and information on the latest risk management requirements. This enables our clients to implement this information at an early development stage to avoid later adjustments.

PROSYSTEM supports you to implement a risk management process according to ISO 14971 by the creation of risk management operating procedures, work instructions, tutorials, templates, and records. During implementation our specialists assist you in defining risk acceptance criteria for your products and lead you through the risk assessment activities and the risk-benefit analysis. During the risk management our specialists introduce the applicable risk management tools.

Please contact us for further details or a non-binding quotation.