Our Medical Training Offer
TÜV Italia Akademie transfers the company's global experience in the most critical aspects of the medical industry into a training offer for those who work in the medical device sector, with courses focused on safety and management of software used in these types of devices.
Quality management managers in medical companies, healthcare professionals involved in the purchase or management of medical devices and regulatory/quality professionals in medical companies are the target audience of these courses, in addition to consultants, assessors and managers of various business functions.
Management, Laws and Regulations
This course explains the role of ISO 13485:2016 within the current regulatory landscape, detailing its mandatory applications across international frameworks and outlining the main differences versus ISO 9001:2015 and the A11:2021 edition.
This training course provides practical tools for effective risk management of medical devices and IVDs across their lifecycle, ensuring a coherent evaluation of safety risks versus benefits in line with EU regulatory requirements and the standard EN ISO 14971:2019+A11:2021.
This course provides a consolidated overview of the key requirements of the EU Medical Devices Regulation 2017/745, highlighting the transition from the former Directives framework, the practical implications for manufacturers, and the competencies needed to apply the updated regulatory obligations effectively.
This course provides an overview of the regulatory framework, the legal context, and the requirements set out in the EU Regulations regarding unannounced audits, along with general examples of practical implementation.
This course helps manufacturers in identifying the regulatory framework applicable to medical and in vitro diagnostic devices with AI-based technologies. Moreover, it provides concepts of High-Risk AI Systems, with a focus on the interplay between MDR/IVDR regulations and the AI Act, and provides basic knowledge regarding the concepts of Artificial Intelligence, AI Systems, deployers, and providers in accordance with the AI Act.
This course provides the fundamentals of computer system validation applied to Medical Devices and In Vitro Diagnostic Devices. Moreover, it presents the main regulatory references governing validation activities, such as EN ISO 13485 and ISO/TR 80002-2:2017, and it provides an overview of the Validation Life Cycle (GAMP 5) and guidance on maintaining validation over the system's life cycle.
Safety and Security
This course delivers a comprehensive introduction to medical-device cybersecurity, covering regulatory frameworks, key international standards, core protection concepts, integration with security and safety risk analysis, secure-software principles, and the essential cybersecurity elements required in the Technical File.
This course provides an integrated overview of European regulatory requirements for standalone and embedded medical software, including MDR/IVDR classification rules, practical approaches to risk management and clinical evaluation, software life-cycle and cybersecurity standards, safe development practices, and the associated technical documentation.
This course delivers a comprehensive introduction to functional safety in medical devices, covering its regulatory foundations, key concepts such as single-fault condition and failure categories, practical application through examples and architectures, and the core validation and documentation requirements within the Technical File.
This course offers a comprehensive overview of biocompatibility assessment for medical devices, covering biological evaluation principles, device categorization, required data and risk assessment, alignment with MDR General Safety and Performance Requirements, gap analysis activities, and expected Notified Body considerations for demonstrating biological safety.
This course delivers practical tools and guided discussions to apply the IEC 62304:2006+A1:2015 standard effectively, covering its requirements, real-world implementation, and best-practice techniques for developing and maintaining medical software.
This training, divided into seven modules, addresses in detail all the aspects and factors that contribute to ensuring the sterility of medical devices: monitoring the whole process from the incoming of raw materials, throughout the manufacturing in an appropriate clean environment, by using a validated packaging system and sterilization process.
This course provides an overview of the key updates introduced by ISO 10993-1:2025, focusing on biocompatibility assessment and its stronger integration with the ISO 14971 risk management system, clarifying expectations for manufacturers and regulatory professionals.
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