ISO 14971 2019 Application of Risk Management to Medical Devices - Awareness Course

Description

ISO 14971 2019 application of risk management to medical devices  specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this standard intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971 2019 application of risk management to medical devices are applicable to all phases of the life cycle of a medical device. The process described in ISO 14971 2019 applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. The process described in ISO 14971 2019 can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle. ISO 14971 2019 awareness course teaches you the process approach and the requirements and benefits of ISO 14971 2019. The essential objective of ISO 14971 2019 awareness course is to create awareness for participants regarding various basic requirements of the ISO 14971 2019 standard & impart working knowledge on how these requirements can be interpreted to suit the organization’s processes, products, people & customers.

Who Should Attend?

• Anyone involved in the manufacturing or development of medical devices
• Organisations that are part of  any phase of the medical device lifecycle
• Jobseekers interested in understanding the best medical device risk management practices
• Anyone looking to gain skills and knowledge to improve their organisation’s medical device quality management system such as ISO 13485 2016

Key Benefits

• Understand the structure of ISO 14971 2019 standard
• Understand the framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices.
• Learn importance and benefits of an ISO 14971 2019 medical device risk management system
• Understand key requirements, terms and definitions of ISO 14971 2019
• Prepare yourself to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
• Learn to create risk management plan and risk management file for medical devices
• Understand the method of managing medical device risk aspects and its impact
• Understand documents and records relevant to ISO 14971 2019 medical device risk management system , critical to the products and services delivered and those required to meet customer and regulatory requirements
• Fill gaps in your professional knowledge

Learning & Evaluation Method

This is  a live and interactive course.  Once you purchase the course, our team will contact you to plan the training. No matter where you are located, we schedule the classes based on your convenience and time zone. You can plan to attend the training in sessions of 4 or 8 hr duration, based on how much time you can spend in a day.

Buy for group Are you planning to buy this course for a group? We have the best prices for you! Select ‘Buy for Group’ option and add to the cart. You will get a discount of 60 – 75% for a group of up to 10 participants. To make a group purchase, create your group name and add individual emails of up to 10 participants. Each participant will get the access to the course materials, exam and the certificate. We will arrange one live-online session for the entire group.