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.
Sessions
Mark your calendar!
*Breakfast, drinks and lunch to be provided by TÜV Rheinland
Meet our Presenters, Topics and Summaries
John McDonald
Cybersecurity Practice Lead
IEC 81001-5-1: Panacea or Placebo?
International medical device cybersecurity certification has traditionally involved a complex patchwork of requirements with minimal commonality between countries, forcing device manufacturers to comply with, submit and track a wide range of disparate activities and documentation. The release of IEC 81001-5-1 was viewed as a way to consolidate multiple submission requirements into one single common framework, with certification providing ‘one submission to rule them all’. This session will review the IEC 81001-5-1 standard, discuss how to leverage it as a foundational framework for a medical device cybersecurity program, and look at its current and future utility as a common international submission certification.
Geoffrey Bock
Business Development Manager
Hazardous Substances and Sustainability
Learn how to refine your due-diligence efforts as it pertains to hazardous substances in materials. As sustainability legislation within Europe transfers from voluntary to mandatory, are your products prepared for ESPR and DPP?
Melissa DiBuono-Russo
Certifier / MDR Expert
Leveraging the Biological Evaluation in Risk Management and Updates to ISO 10993-1
(Boxborough)
The Evaluation of Biological Safety is a key process in ensuring a medical device is ready for market distribution. Leveraging the risk assessment and clinically relevant information is key in ensuring that unnecessary animal testing is reduced. This presentation will also include information regarding the anticipated updates to ISO 10993-1 – Biological Evaluation of Medical Devices – Part 1: General principles and requirements within a risk management process.
Tiffany Wong
Product Manager – MAS, US
Strategic Global Market Entry for Medical Devices
This presentation will introduce the advantages of leveraging integrated testing in pursuit of international certifications for medical devices. We will also highlight the certification requirements for the most sought-after countries.
Gregory Chase
Technical Manager, CB Certifier
Medical Product Safety, a Practical Guide to the Certification Process
IEC 61010 establishes general safety and performance requirements for electrical equipment used in medical, measurement, control, and laboratory settings. It works in conjunction with horizontal medical standards (applicable to all device types), vertical medical standards (device-specific requirements), and horizontal reference standards (relevant cross-industry guidelines) to create a comprehensive framework for medical product testing and compliance. This structure ensures that medical devices meet both overarching safety principles and specific requirements relevant to their function and technology.
Jeremy Cosby
Practice Lead – Advanced Cyber Defense
Securing Medical Devices: The Role of Penetration Testing in Ensuring FDA Compliance
The session will provide actionable insights into integrating penetration testing into the 510(k) submission, supported by real-world case studies. We will discuss best practices, tools, techniques for effective testing, and strategies to overcome common challenges. Join us to learn how thorough penetration testing ensures compliance with FDA guidelines and fortifies the security of medical devices against emerging threats.
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