Who is the course for

This is a three-day course delivered as a stand-alone or as part of the Clinical Engineering Applications program here at Eastwood Park. It is ideally suited to those who are involved in or are aspiring to progress into through life medical device risk management, technical management, and internal auditing within a healthcare environment. The course delivers the principles, through a series of presentations, and supported by group assignments. The course governance is underpinned by the guidance produced by the Medicines and Healthcare products Regulatory Agency, (MHRA), British Standards, (BS EN ISO 14971, BS EN ISO 13485, BS 70000), and Medical Device Regulations 2002.

Aims & objectives

Underpin the knowledge, principles, techniques, and financial aspects to facilitate effective procurement, safe management and delivery of through life equipment support to medical device assets.

BY THE END OF THE COURSE YOU WILL BE ABLE TO:

• Define the risks associated with the, acquisition, deployment, and in-service use of medical devices and apply risk management techniques to facilitate mitigation of risk.
• Explain the role of the Medicines and Healthcare products Regulatory Agency, (MHRA), serious defect reporting and Field Safety Notices, (FSN) and Management of Medical Devices
• Write an equipment support plan for the environmental usage, level of repair, setting the service intervals and disposal of a medical device
• Set the framework for the technical assurance of the medical device maintenance environment and contract monitoring
• Calculate the depreciation and though life costs of a medical device
• Internal Quality Audit Principles and Practice.