Risk Management according to ISO 14971:2019

ONLINE

*MDR – EU Medical Device Regulation

During this one-day course you will get a good understanding of the key requirements that shall be fulfilled to establish and maintain a risk management system in compliance with 14971:2019 and its relation to EU and US Medical Device regulations.

This standard is since December 2019 also on FDAs list of so called “Recognized Consensus Standards”

New Regulatory Environment

New technology enables new effective diagnostic and therapeutic methods as well as new challenges in controlling new hazards. Manufacturers of medical devices are expected to comply with a more demanding regulatory environment as effectively reducing risks, as low as possible for patients and bystanders. It is essential to establish processes that are aligned with the state of the art related to technologies used as well as an effective state of the art risk management process.

Course description

The course provides practical guidance on how to implement the requirements of EN ISO 14971:2019 in your quality management system. We will discuss how the risk management procedure relates to other processes such as design and development, verification and validation, clinical evaluation, post-market surveillance and usability and how this is reflected in the quality management system. 14971 stipulates that the risk management process shall be reviewed at regular intervals -we will show how this can be integrated into your management review and internal audit program.

During the course you will also get a thorough understanding of EN ISO 14971:2019, as compared to the 2012 version as well its relation to the new Medical Device regulations.

Course outline

• Purpose of risk management
• Planning of the risk management process
• Risk assessment and risk control
• Risk review and overall residual risk acceptability
• Use of post-market surveillance in risk management
• Implementation of risk management in your quality management system
• MDR, 14971:2019 and the harmonization process

Learning objectives

• Know how to interpret and implement the requirements of 14971:2019 in your quality management system
• Define key input and output of the risk management process
• Understand the lifecycle approach to risk management
• Identify the links between ISO 13485:2016, ISO 14971:2019 and the medical device regulations

Who should attend

The course is suitable for persons working with R&D, production, process development or QA who is involved in, or responsible for the operation or audit of a Risk Management System for medical devices.

Prerequisites

• You should have basic knowledge of quality systems
• You should have some experience from the medical device industry

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