Comprehensive Training for Electrical-Based Medical Devices Sold in the USA and European Union
This seminar, offered by TÜV Rheinland, is designed to provide in-depth knowledge and practical skills related to the development, compliance, and safety aspects of electrical-based medical devices sold in the USA and the European Union (EU). Taught by experts in the field, this course covers essential topics such as IEC 60601 product safety, EMC IEC CB reports, REACH and RoHS compliance, and cybersecurity.
Outline
1. Introduction to Electrical-Based Medical Devices
Overview of medical device regulations in the USA and the EU
Understanding the importance of compliance and safety
2. Cybersecurity for Medical Devices
Penetration testing for Medical Devices
FDA's Medical Device 2022 Pre-Market Guidance
EU integration to ISO 81001
Comparison of FDA & ISO 81001
3. Managing the Impact of Hazardous Substances in Medical Products
Overview of RoHS, REACH and CLP for Invasive Material regulations
Understanding the impact of these regulations on medical device manufacturing
Identifying restricted substances and compliance strategies
Documentation and reporting requirements for Hazardous Substances in Medical Products
4. How to Understand and Interpret IEC CB Reports for EMC
Electromagnetic compatibility (EMC) requirements for medical devices
Understanding IEC CB reports and their significance in international compliance
Test methods and procedures for EMC testing
Interpretation and utilization of IEC CB reports for market access
5. IEC 60601 Product Safety, a Practical Guide to the Actual Certification Process
Brief Introduction to IEC 60601 standard and its application to medical devices
General overview of evaluation, testing and certification processes for compliance
As a device manufacturer, how do I know that I am fully prepared to start?
Most common mistakes or pitfalls with submissions and how to avoid them
Format: The seminar is conducted in a classroom setting, combining lectures, presentations, case studies, and interactive discussions. The duration of the seminar is Five hours including a one hour lunch catered by TUV. Each of the four subjects will take about 40 minutes and will allow 20 minutes for group interaction and questions.
Who Should Attend: This course is suitable for professionals involved in the development, manufacturing, quality assurance, regulatory affairs, and compliance of electrical-based medical devices intended for sale in the USA and the European Union. It is particularly beneficial for engineers, product managers, regulatory specialists, and other professionals seeking comprehensive knowledge in medical device compliance and safety.
Meet our Presenters
Geoffrey Bock
Gregory Chase
Jeremy Cosby
John McDonald
Kelsey Brown
Robert Mitchell
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