Master Change Control with Orcanos

FMEA (Failure Mode and Effects Analysis) is a systematic approach used in medical device risk management to identify potential failures in a product, process, or design. By analyzing failure modes, their causes, and effects, manufacturers can proactively mitigate risks, ensuring product safety and compliance with standards like ISO 14971.

ISO 14971 is the international standard for risk management in medical device manufacturing. It requires manufacturers to identify hazards, evaluate associated risks, and implement controls to reduce those risks. Compliance ensures the safety and effectiveness of medical devices while meeting regulatory requirements worldwide.

PFMEA (Process FMEA): Focuses on identifying risks in manufacturing and production processes.
DFMEA (Design FMEA): Analyzes risks in the product's design phase, ensuring reliability and functionality.
UFMEA (Use FMEA): Examines risks associated with how end-users interact with the device, focusing on user error and usability issues.
Each type serves a specific stage of product lifecycle risk analysis, and using all ensures comprehensive risk management.

Orcanos simplifies ISO 14971 compliance by automating risk calculations, generating risk management documentation (RMF), and integrating design and quality management modules. It offers tools for FMEA analysis, real-time risk tracking, and customizable workflows to streamline processes and maintain traceability, reducing the effort required for compliance.