This course supports the IHEEM selection and IHEEM registration of Authorising Engineers Medical Engineering. The course covers key aspects of the role, such as external auditing, risk management, training and awarding of competence, and much more. The course governance is underpinned by the guidance produced by the Medicines and Healthcare products Regulatory Agency, (MHRA), British Standards and Medical Device Regulations.
This course is ideally suited to medical/clinical engineers who are seeking IHEEM registration as an Authorising Engineer Medical Engineering, (AEME). This course may also be of interest to other roles such as Medical Device Safety Officers, (MDSO) and those given the authority as a Designated Person for medical engineering.
To equip experienced engineers, who are seeking appointment as an AE(ME), with the behaviours, knowledge and skills required to be effective as an Authorising Engineer, Medical Engineering
· Explain the roles played by various regulatory bodies (MHRA, CQC, HSE) and individual roles in UK healthcare
· Accurately describe the function of a Medical Device Management System (MDMS) and identify potential weaknesses
· Identify the problems associated with procurement & replacement equipment programs for medical devices
· Apply the principles, reasons for non-compliance and advanced topics when conducting a medical device technical audits
· Discuss the distribution, format, methods of feedback and application of RAG ratings within audit report writing
· Demonstrate knowledge of the statutory, mandatory reporting systems and process for investigation of medical device Incidents/ Accidents
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Our extensive practical facilities give learners the chance to gain valuable hands-on experience within a safe and controlled environment.
The Authorising Engineer Medical Engineering (AE(ME)) course prepares experienced healthcare engineering professionals for the strategic Authorising Engineer role. It focuses on medical device governance, independent auditing, risk management, medical device management systems (MDMS), incident investigation and leadership within healthcare organisations. The course supports professionals seeking IHEEM registration as an Authorising Engineer (Medical Engineering).
An Authorising Engineer (Medical Engineering) acts as an independent technical adviser, providing assurance that healthcare organisations manage medical devices safely and effectively. The role includes reviewing governance arrangements, carrying out technical audits, assessing competence, supporting incident investigations and advising on compliance with MHRA guidance, relevant British Standards and medical device regulations.
Yes. Learners develop an understanding of medical device governance, advanced auditing techniques, audit report writing, risk management and the principles of assessing compliance with medical device management systems. The course also explores how to identify weaknesses within existing systems and recommend improvements.
Yes. This course has been developed to support professionals seeking selection and registration with IHEEM as an Authorising Engineer (Medical Engineering). It equips experienced engineers with the knowledge, behaviours and skills expected of the AE(ME) role, although successful completion of the course does not automatically guarantee registration or appointment.
Eastwood Park Training is one of the first providers to deliver a dedicated Authorising Engineer Medical Engineering course. Developed alongside the review of the AE(ME) role and supported by specialist healthcare engineering expertise, the course combines governance, auditing and technical leadership with practical healthcare engineering knowledge to prepare experienced professionals for this strategic role.