Medical devices are necessary in the healthcare industry as they greatly aid in patients' diagnostic and treatment processes. However, these devices have great benefits but can also come with significant risks.
Due to the nature of medical devices, strict regulations surrounding them have been established through ISO 14971. This legislation focuses on the risk management aspects of medical devices and states what is required to ensure machine safety. It primarily explores the types of risk analysis methods and processes that should be used.
Furthermore, risk management encompasses the entire process of identifying risks, assessing, and analysing them. Generating a deep understanding of all probable risks will allow for accurate preventative measures and corrective actions to be implemented. If guidelines are followed correctly, significant risks will be reduced completely, and residual risks will be easier and safer to manage.
Upon completion of this course, participants will be able to:
This course is designed for anyone within healthcare responsible for maintaining medical device safety and reducing risks. It would be most beneficial for:
This course uses a variety of adult learning styles to aid full understanding and comprehension. Participants will review example documents of risk assessments and analyse risk data to highlight the types of risks identified and how best to prevent them.
They will be provided with all the needed tools and equipment to participate in the learning methods and exercises, which include presentations, video materials, discussions, and group activities. This combination of individual and group exercises will guarantee that the participants will develop a strong understanding of the taught content and related practical skills.
Section 1: Introduction to Risk
Section 2: Comprehending ISO 14971
Section 3: Conducting Risk Assessments
Section 4: Analysing Risk Data
Section 5: Implementing Risk Management
Upon successful completion of this training course, delegates will be awarded a Holistique Training Certificate of Completion. For those who attend and complete the online training course, a Holistique Training e-Certificate will be provided.
Holistique Training Certificates are accredited by the British Accreditation Council (BAC) and The CPD Certification Service (CPD), and are certified under ISO 9001, ISO 21001, and ISO 29993 standards.
CPD credits for this course are granted by our Certificates and will be reflected on the Holistique Training Certificate of Completion. In accordance with the standards of The CPD Certification Service, one CPD credit is awarded per hour of course attendance. A maximum of 50 CPD credits can be claimed for any single course we currently offer.