ISO: 14971 Risk Management – 2 days - Virtual Classroom
28-29 Apr 2022 8 Delegates Maximum per training
€699 Price includes training, all training materials, certification and refreshments during the training where applicable. Need a quote for In-house Training email us today info@iqc.ie Introduction The requirements for Product Risk Management as it pertains to all stages of a Medical Device Lifecycle is outlined in ISO 14971. This course will evaluate and focus on the requirements of the ISO 14971 in detail and will demonstrate Risk Management practices that reflect best in class. During the course participants will acquire knowledge and skills to implement an effective Risk Management system in conformance to ISO 14971. Risk Management, like any other system, evolves over time within a company as knowledge grows and frequent reviews are conducted. Hence, the best place to practice and extend your experience is in reviewing one’s current system, conduct a gap analysis and determine if current established requirements are sufficient to meet applicable regulatory requirements. Who should Attend: All personnel involved in areas relating to: Product Development R&D Quality Production Manufacturing Procurement Engineering Supplier Management Outsourced Process Management should be conversant with these requirements to provide assurance of Competency in Medical Device Product Risk Management per Clause 4.3 of ISO 14971:2019 Join us for a 2 - day course that will build and enhance your competency on ISO 14971:2019. This is an on-line course with an expert tutor that currently works in the Medical Device industry. DAY 1 and DAY 2 are interconnected, but independent. Cancellations Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.
