Description

Application of Risk Management to Medical Devices as per ISO 14971:2019

Master the International Standard for Managing Risk Throughout the Medical Device Lifecycle

 

In the critically regulated medical device industry, effective risk management is not just a best practice—it's a fundamental requirement for patient safety and regulatory compliance. The ISO 14971:2019 standard is the globally recognized benchmark for the application of risk management to medical devices, including software and in vitro diagnostics. This focused training is your definitive guide to understanding, implementing, and maintaining a risk management process that identifies hazards, estimates and evaluates associated risks, and implements effective controls throughout all phases of the device lifecycle.

 

Actionable takeaways for your Job Role

By the end of this training, you will be able to confidently:

  • Define Risk Management Terminology as specified in ISO 14971:2019, ensuring a common understanding across your organization.
  • Outline the Stages of the complete risk management process, from risk analysis to production and post-production monitoring.
  • Develop Key Deliverables of the risk management process, including the Risk Management Plan and Risk Management Report.
  • Apply Risk Management Principles effectively within your organization to address risks related to usability, biocompatibility, data security, and more.
  • Identify the Crucial Links between ISO 14971:2019 and ISO 13485:2016 for an integrated Quality Management System.
  • Apply Knowledge Practically through real-world case studies and interactive workshops that simulate common medical device challenges.

 

Quality & Excellence Performance Metrics

Post-training, you will drive these quality parameters to ensure operational excellence, in your job-role:

  • Map organizational risk management practices against ISO 14971:2019 requirements.
  • Develop a comprehensive Risk Management Plan for medical devices.
  • Identify and document hazards and hazardous situations associated with medical devices.
  • Estimate and evaluate risks using appropriate risk assessment methodologies.
  • Identify, implement, and verify effectiveness of risk control measures.
  • Evaluate residual risks and document overall residual risk acceptability.
  • Establish and implement monitoring activities for production and post-production phases.
  • Prepare comprehensive Risk Management Reports for medical devices.
  • Integrate risk management with ISO 13485:2016 Quality Management System processes.
  • Ensure risk management documentation meets regulatory requirements.

 

Course Curriculum

The course is structured into digestible modules, designed for optimal learning flow:

  • Module 1: Introduction to ISO 14971:2019 - Principles, Terminology, and Lifecycle Approach
  • Module 2: The Risk Management Process: Risk Analysis, Evaluation, and Control
  • Module 3: Production and Post-Production Activities: Monitoring and Feedback Integration
  • Module 4: Key Deliverables and the Integral Link with ISO 13485:2016
  • Module 5: Practical Workshops, Case Studies, and Interactive Q&A Sessions

 

Job Roles That Will Benefit

This training is essential for professionals involved in the development, production, quality assurance, and regulation of medical devices, including:

  • Quality Assurance and Quality Control Professionals
  • Regulatory Affairs Personnel and Management Representatives
  • Internal Auditors and Assessors
  • Process Owners, Engineering Managers, and R&D Staff
  • Software Developers and Design Engineers in the medical device industry
  • Anyone responsible for implementing or maintaining a risk management system for medical devices

 

Prerequisites

While there are no formal prerequisites, it is highly recommended that participants have a basic understanding of risk management concepts and the medical device industry to maximize their learning.

 

Course Features & Included Materials

  • Interactive Learning: Engage in scenario-based workshops to reinforce understanding.
  • Expert-Led Sessions: Participate in dedicated Q&A sessions with experienced professionals in medical device risk management.
  • Comprehensive Learning Materials: Digital Learning Materials and a copy of ISO 14971:2019 (For Training Purposes only).
  • Knowledge Evaluation: Gauge your understanding with Pre and Post-training Evaluation..
  • Certificate of Training: Earn a verifiable, with a unique ID and QR code, soft-copy certificate issued via the QCI training portal. Validate your achievement anytime at https://pathshala.qcin.org/.

 

Enroll Today and Fortify Your Medical Devices with Proactive Risk Management!

Invest in your skills to enhance patient safety, ensure regulatory compliance, and build a culture of quality and vigilance within your organization. Gain the knowledge to implement a robust risk management process that protects patients, satisfies regulatory bodies, and demonstrates your commitment to excellence in the medical device industry.

 

For more information, please contact:

Rohit Varshney at rohit.varshney@qcin.org or call +91 97735 00376