REGU09009 2019 Risk Management, Labelling and Promotion

Demonstrate they have detailed knowledge and understanding of the content and application of ISO 14971: Medical devices - application of risk management to medical devices & risk management planning and the key components of a risk management file.

Implement a risk management plan including risk analysis, risk evaluation, implemetation of appropriate risk controls and conduct a risk/benefit analysis.

Communicate they have a detailed knowledge and understanding of the EU/US/Global legislation and regulations associated with medical device labelling and global perspectives on UDI, harmonised symbols, structure of IFU, intended use, contraindications, label / IFU review best practice , elabelling.

Demonstrate they have a detailed knowledge and understanding of the legislation and regulations associated with medical device advertising and promotion from EU/US and Gobal perspective and also country specific requirements.

Communicate a detailed knowledge of context of off label use/on label use and particular requirements for website content.

Evaluate the relevance of social media (twitter, blogs..) and future directions for advertising and promotion. Evaluate the place of physician /customer contact and direct to consumer advertising in promotion strategy.

Formulate and communicate judgements from a regulatory standpoint in each step of the risk management process and demonstrate ability to interact effectively with regulatory agents.

The educational elements will be provided by the Institute of Technology Sligo, NUI Galway and NIBRT staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. Online/blended programmes are designed for students who want to study part-time at a pace that matches their work-life balance. Through a combination of blended delivery formats including online (synchronous and asynchronous) as well as other technologies we strive to reach the forefront of emerging breakthroughs in the delivery and assessment of online students.

The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.

Sample Technologies in use during assessments
• Moodle
• Adobe connect
• Turnitin
• Panopto
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos

The programme allows students to progress to a next stage if they have failed to attain the pass mark for a particular module. A student may be allowed to carry up to 10 credits into a new stage. This policy is at the discretion of the examination board.

The following is a summary of the main topics included in this particular module: Applicaton of Risk Management to medical devices; Medical device labeling and advertising regulations; product release, commercialization requirements; UDIs; individual country requirements;elabelling; social media; ethical and environmental issues.

Demonstrate an awareness of current issues impacting the medical device industry and understand ethical and philosophical issues attached to these.

Demonstrate they have knowledge of key environmental legislation applicable to the medical device industry. Evaluate and assess key environmental legislation relating to recycling issues and packaging of medical devices.