Topical issues in the field of medical engineering
TÜV SÜD Akademie GmbH is one of the leading continuing training partners for national and international companies of all sizes and industries. The qualifications and certifications it awards to persons in the fields of engineering, management and health satisfy the highest quality requirements and are renowned throughout the world.
The following seminars for medical device manufacturers have now been added to the program:
Requirements of IEC 60601-1, Amendment 1
The seminar starts by explaining the reasons that led to the revision of the standard and goes on to address the Standard′s key changes in the fields of risk management, user manuals, labeling, insulation coordination, and mechanical hazards. Participants will hear how the changes in the new IEC 60601-1 will affect practice and, using examples from practice, will learn how to implement the updated requirements. The seminar targets manufacturers and component manufacturers of electrical medical equipment and employees in product design and development, regulatory affairs, and quality management.
Agile methods of software development for medical devices
The seminar delivers an overview of the agile methods of software development, comparing them to conventional predecessor models such as Scrum and Kanban. Comparison based on AAMI TIR 45 focuses on the objectives, values, concepts, and practices of regulatory requirements.
Participants will learn how agile methods can be reconciled with the regulatory requirements in the EU and US markets and how to convincingly present compliance in quality management processes and audits. The experts also examine how the requirements of risk management and usability can be mapped in agile processes and how users can meet these requirements.
In the seminar, TÜV SÜD experts address the EN ISO 17664 standard harmonized under the Medical Device Directive 93/42/EEC and the requirements for medical device manufacturers resulting therefrom. The seminar also takes a close look at the individual steps of the process: cleaning, disinfection, and sterilization of medical devices. The event thus teaches the essential requirements for the documentation of validation and the reprocessing of medical devices required by manufacturers. In addition to fundamentals of microbiology, the agenda covers legal regulations, risk management, and requirements on disinfectants and sterilization.