ISO 14971:2019

ISO 14971 is an international standard for the medical device sector, covering risk management. This standard establishes best practices throughout the whole life cycle, from design to distribution, and maintenance. ISO 14971 also includes a detailed glossary of terms and definitions. It is critical for your company to ensure that its goods are both safe and effective; thus a risk management strategy is essential.

ISO 14791 and ISO 13485:2016 are linked, since they help develop a functional and risk-aware QMS. ISO 13485 is a standard for medical devices that focuses on regulatory and customer needs. ISO 13485 turns to ISO 14971 for guidance since it involves risk analysis and record-keeping for all risks. When it comes to risk management requirements, ISO 14971 is more specific.

When it comes to medical devices, ISO 14971 provides a framework for developing a risk management plan for your company. The chance and frequency of harm can be assessed, studied, and controlled from the first analysis to risk control and evaluation.