This 2 day seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Device Regulation (IVDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others.
We will review the latest changes to the regulations effective and in force for 2020 and will draw out key developments and key dates with particular emphasis on requirements for US firms shipping materials, parts, and products to the European Union.
Areas Covered :
Topics covered in this seminar include:
Who will Benefit:
This webinar will provide valuable assistance to all personnel in:
Ms. Eisenhardt is Co-Founder and Managing Director at BlueCircle Advisors LLC, a consulting firm that provides strategy and programming to address product compliance risks, sales and revenue protection, and compliance and sustainability practices throughout the supply chain.
With 20 years’ experience in IT and Compliance Software Development, her former roles include: Executive Director of Environmental Programs, at Fair Factories Clearinghouse; Environmental Compliance Manager and Design for Environment programs at EMC Corporation; and Director of Product Management at PTC Corporation for Windchill Product Analytics – an environmental compliance software.
She is a journalist for industry trade publications such as 3BL, JustMeans, Social Earth, CSRwire, Ethical Performance, and CSR@Risk with a focus on trends in product compliance, supply chain transparency, and corporate social responsibility.
In 2015, she traveled with Asia Pulp and Paper to Indonesia and Sumatra to research and write about the company’s zero deforestation efforts and social responsibility programs.
In May 2016, she delivered her paper on “Advancing Product Design with Environmental Compliance,” at the IEEE/ISCPCE conference in Anaheim, California. She is currently on assignment with an IT infrastructure company to build Corporate Social Responsibility (CSR) programs specializing in anti-trafficking compliance, sustainability programming and reporting, and cybersecurity compliance for supply chains.