EN ISO14971:2019 - Risk management - in relation to MDR and ISO13485

– understand its importance and relation to MDR and EN ISO13485:2016

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

This webinar provides guidance on how to implement the requirements of EN ISO 14971:2019 in your quality management system and how to deal with critical elements of the quality management system.

During the course you will also get a thorough understanding of the major changes in the newly updated EN ISO 14971:2019, as compared to the 2012 version as well its relation to the new Medical Device regulations (MDR/IVDR)

Course content

• Risk management requirements in MDR
• Requirements in EN ISO 13485:2016
• EN ISO 14971:2019, updated risk management process and new definitions
• Risk management for a medical device, different methods
• Risk acceptance criteria’s
• Risk estimation, risk evaluation and risk control
• Documentation requirements

Learning objectives

Participants will get to know the key elements of a risk management system in line with the requirements in EN ISO 14971:2019 and MDR. Completion of this course will give you the knowledge needed to assess and update your current risk management process

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 who need to know the changes introduced in ISO14971:2019 (EN ISO 14971:2019).

Prerequisites

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