At EUmAccess GmbH, we assist medical device and in vitro diagnostic (IVD) manufacturers in implementing ISO 14971:2019-compliant risk management processes to ensure device safety and regulatory compliance under MDR 2017/745 and IVDR 2017/746.
What is ISO 14971:2019?
ISO 14971:2019 is the international standard for risk management of medical devices and IVDs. It provides a systematic approach to identifying, evaluating, controlling, and monitoring risks throughout the device lifecycle.
Mandatory for MDR & IVDR compliance
Applies to all medical devices & IVDs
Ensures patient & user safety
Required for CE Marking & regulatory approval
Key Requirements of ISO 14971:2019
Risk Management Plan
- Establish a structured risk management process
- Define responsibilities, acceptance criteria & risk-benefit analysis
Risk Identification
- Identify potential hazards related to:
- Device design & materials
- Manufacturing processes
- Software, usability & cybersecurity risks
- Sterilization & biocompatibility
- Clinical use & post-market scenarios
Risk Analysis
- Estimate the probability & severity of harm
- Identify risk sources from design, usage, and external factors
Risk Evaluation
- Compare risk levels against acceptable criteria
- Determine whether risk control is required
Risk Control Measures
- Implement measures to reduce or eliminate risks:
- Inherent safety by design (e.g., material selection)
- Protective measures (e.g., alarms, software safeguards)
- Information for users (e.g., labeling, IFU warnings)
Residual Risk Evaluation
- Assess remaining risks after control measures
- Perform a risk-benefit analysis
Risk Management Report
- Document all risk management activities
- Ensure compliance with ISO 14971 & MDR/IVDR requirements
Post-Market Surveillance (PMS) & Risk Monitoring
- Continuously monitor risks through PMS & vigilance systems
- Update risk assessments based on real-world data
How We Help You Comply with ISO 14971:2019
Risk Management Plan Development
- Creating a structured risk management process
Hazard Identification & Risk Analysis
- Conducting a detailed risk assessment
Risk Control & Residual Risk Evaluation
- Implementing effective risk mitigation strategies
Documentation & Compliance Support
- Preparing ISO 14971-compliant risk management files
Training & Workshops
- Educating teams on risk management best practices
Why Choose EUmAccess GmbH?
- ISO 14971 Experts – Ensuring smooth compliance with risk management requirements
- End-to-End Risk Management Support – From planning to post-market monitoring
- Fast & Efficient Process – Helping you meet regulatory deadlines
- Regulatory Compliance Assurance – Ensuring alignment with MDR 2017/745 & IVDR 2017/746
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.