Europe-CE Marking MDR / IVDR

Risk Assessment for Medical Devices – ISO 14971:2019

Risk Assessment for Medical Devices – ISO 14971:2019

At Alpine Quality Consultants, 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 AQC?

Contract Manufacturers & Suppliers

ISO 14971 Experts

Ensuring smooth compliance with risk management requirements

EU Authorized Representatives

End-to-End Risk Management Support

From planning to post-market monitoring

Distributors & Importers

Fast & Efficient Process

Helping you meet regulatory deadlines

Medical Device & IVD Manufacturers

Regulatory Compliance Assurance

Ensuring alignment with MDR 2017/745 & IVDR 2017/746

Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

BH-403, Fourth Floor 81 High Street, Business Hub, Sector 81, Faridabad, Haryana 121002, India

Links

Services

Contact

© Alpine Quality Consultants 2025 | All Rights Reserved

TOP