Clinical Engineering and Medical Technology Management: Advanced

Clinical Engineering and Medical Technology Management: Advanced

Clinical Engineering: AEM, Adverse Events & Cybersecurity

Clinical Engineering and Medical Technology Management: Advanced

Build a defensible AEM program under The Joint Commission, investigate adverse events under 21 CFR Part 803, and manage post-market cybersecurity of networked medical devices.

BME-619-AAdvanced32 hoursCertificate of Completion

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Clinical Engineering and Medical Technology Management
FormatProfessional Certificate Course
LevelAdvanced
Duration32 hours
LanguageEnglish
CertificateCertificate of Completion: Aleph University
Full course trackIntroductory (16 h) + Advanced (32 h) = 48 hours
Prerequisite / Recommended Preparation

Recommended prerequisite: completion of the Introductory level for this training, or relevant professional experience subject to Aleph University review.

Overview

Building on the lifecycle foundation of the Introductory level, this Advanced course develops the regulated, high-stakes side of hospital technology management: Alternative Equipment Management, adverse-event investigation, user-facility reporting and post-market cybersecurity.

This 32-hour Professional Certificate Course covers AEM programs under The Joint Commission EC.02.04.03 and CMS Conditions of Participation; adverse-event investigation and root-cause analysis with user-facility reporting under 21 CFR Part 803; post-market cybersecurity aligned with the FDA September 2023 guidance and patch deployment across clinical fleets; networked medical devices and IT integration under IEC 80001-1; and technology obsolescence and retirement.

By the end, participants can build an AEM program defensible in a Joint Commission audit, investigate an adverse event to root cause, distinguish reportable user-facility events under 21 CFR Part 803 and hold a technical conversation with hospital leadership about device cybersecurity.

What you will learn
Build an Alternative Equipment Management (AEM) program under The Joint Commission EC.02.04.03 expectations.
Analyze an adverse-event case to determine root cause and corrective action.
Differentiate reportable user-facility MDR events from non-reportable ones under 21 CFR Part 803.
Evaluate cybersecurity patch deployment across a fleet of clinical equipment.
Communicate clinical-engineering recommendations to hospital leadership and clinical stakeholders.
course topics & modules
Professional relevance

The Advanced course connects hospital operations to the manufacturer’s post-market obligations: AEM auditing, adverse-event reporting and device cybersecurity, preparing participants to lead defensible programs in clinical-engineering, quality and patient-safety roles.

Certificate of Completion

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.

Completion of both the Introductory and Advanced levels may be reviewed by Aleph University for potential recognition within an applicable graduate pathway, subject to institutional review and applicable academic policies. Recognition is not automatic and is not guaranteed.
Frequently asked questions
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