What is ISO 14971?
ISO 14971 is the international standard that establishes the requirements for risk management for medical device companies. It established guidance for risk analysis, evaluation, control and management, and also specifies procedures to review and monitor throughout production and post-production. The ISO 14971 requirements are harmonized with Europe’s medical device regulations (MDR).
Benefits of ISO 14971 Risk management to medical devices
- In-depth understanding of risk mitigation: ISO 14971 is the international standard for risk management in medical devices. By undergoing training and certification, participants gain a comprehensive understanding of the principles and requirements of risk management according to ISO 14971:2019. This knowledge allows individuals to effectively identify, assess, and mitigate risks associated with medical devices.
- Compliance with regulatory requirements: ISO 14971 is widely recognised and accepted by regulatory authorities worldwide. By obtaining certification, individuals and organisations demonstrate their commitment to meeting regulatory requirements and ensuring the safety and effectiveness of their medical devices.
- Improved decision-making: ISO 14971 provides a systematic approach to risk mitigation, enabling informed decision-making throughout the product lifecycle. By understanding the principles and processes outlined in the standard, individuals can make well-informed decisions regarding risk acceptance, risk mitigation strategies, and risk control measures.
- Competitive advantage: Certification in ISO 14971 can provide a competitive edge in the medical device industry. It demonstrates a commitment to quality, safety, and compliance, which can enhance the reputation and credibility of individuals and organisations.