Risk Management ISO 14971 Consulting for Medical Device and IVD Companies
Expert guidance to help you navigate ISO 14971:2019 compliance, mitigate risks, and ensure the safety and effectiveness of your medical device or IVD throughout its lifecycle.
Essential Role of ISO 14971 in Medical Device Risk Management
Robust risk management is a regulatory imperative for medical devices. Many medical device regulators around the world have centered risk management in their regulatory frameworks and recognize ISO 14971, the international standard on risk management. The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR) implicitly require medical device and IVD manufacturers to establish, document, implement, and maintain a risk management system in accordance with ISO 14971:2019.
Risk management is baked into Post-Market Surveillance (PMS), Clinical Evaluation, and the Quality Management System (QMS), particularly ISO 13485:2016, so a deep understanding of how it intersects with other functions is essential to any successful risk management implementation. Most device manufacturers need expert help to develop an effective, ongoing strategy
What is Medical Device Risk Management?
Risk management for medical devices prioritizes product safety with the goal of reducing risk to an acceptable level. Risk acceptability varies but is established based on applicable regulations and relevant standards, the state of the art, and the concerns of management and stakeholders. Financial or corporate risks are not addressed in ISO 14971. However, safer products mean the companies who make them will face fewer liabilities throughout the life of the device. Risk management benefits everyone in the device ecosystem, from the manufacturer to the patient.
ISO 14971 Risk Management Process for Medical Devices
Risk management is the process of systematically identifying, evaluating, controlling, and monitoring potential hazards associated with the device’s use. It is continuous, meaning risk management occurs throughout the device lifecycle, from design to post-market until your device is no longer being used. Under 14971:2019, risk management is a multistep process that includes:
- Risk planning
- Risk assessment
- Risk evaluation
- Risk controls
- Production and post-production activities
It is also a multidisciplinary project that requires personnel with risk management, quality, regulatory, and clinical competencies.
ISO 14971 medical device risk management experts
MedEnvoy’s risk management capabilities are informed by deep expertise with regulatory expectations and industry best practices that align with ISO 14971. Our team of regulatory and medical device experts have executed risk management procedures to ISO 14971:2019 and across multiple markets. We can help you implement risk management processes from the earliest stages of development to post-production.
How we can help:
Comprehensive risk management planning
Risk management begins with thorough planning and documentation, which is required as part of your marketing authorization submission in many markets, particularly the European Union. We will help you design and document the best strategy to identify hazards, analyze risks, and implement risk controls.
Analyze risks and identify and implement risk controls
Using proven risk assessment methodologies, we will identify hazards associated with your device and their potential occurrence and severity of harm. From there, we work with your team to prioritize and implement risk controls that will reduce the likelihood and severity of risk according to the established risk acceptability criteria.
Residual risk-benefit analyses
Ongoing evaluation considers residual risks that might be present even after controls are in place. We can help you weigh residual risks against the medical benefits of your device to determine if further risk controls are required to reduce the likelihood of adverse events and product recalls.
Lifecycle risk monitoring
Our team will establish processes and procedures to support ongoing risk monitoring that also integrate with your quality management system and post-market surveillance activities.
Documentation writing and support
Regulatory authorities require extensive risk management documentation to demonstrate compliance with ISO 14971. Our team provides support in preparing and maintaining your Risk Management File, including risk management reports, post-market risk updates, and regulatory submission support for FDA, EU MDR/IVDR, and other agencies.
