2-Day Virtual Seminar

Fundamentals of EU MDR and IVDR – Level 1

BY: Kelly Eisenhardt, Co-Founder and Managing Director at BlueCircle Advisors LLC

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

June 24-25, 2021
(8:00 AM to 2:00 PM PDT)
Virtual Seminar
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

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.

Learning Objectives:

After completing this seminar, you will gain a better understanding of:

  • Reasons for the Medical Device Regulation
  • Structure and objectives of the MDR
  • Timeline for transition
  • Difference between the old requirements (MDD) and the new (MDR)
  • Ability to identify the lifecycle of a device and the requirements of the various stages – premarket, design and development, product realization, and post market
  • Understand the impact of the regulation changes on “economic operators” (Articles 11, 13, 14)
  • How to transition from the old directives to the new regulation
  • Identifying high risk devices
  • General safety and performance requirements (GSPR Annex 1)
  • Review Common Specifications (CS)
  • Connection between MDR and ISO 13485:2016
  • Technical file requirements and reviews
  • UDI and traceability
  • Linking to the Quality Management System (QMS)
  • Steps of a gap assessment “As Is” and “To Be” for transitioning to new compliance requirements
  • Basic understanding of the EUDAMED database for post market surveillance
  • Preparing for transition to MDR
Who will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • Manufacturers, distributors, and importers of medical device equipment
  • Quality and regulatory affairs
  • Product engineers focused on medical device products
  • Corporate risk management teams
  • Suppliers to medical device companies
Day 01(8:00 AM - 2:00 PM PDT)
  • Introduction/review of Medical Device Regulation and timeline
  • Differences between the old and new version (MDD/MDR)
  • Lifecycle of a Device, Process pre and post market
  • Transitioning to the new requirements
Day 02(8:00 AM - 2:00 PM PDT)
  • Compliance procedures and Quality Management Systems
  • General safety and performance (GSPR) and Common Specifications (CS)
  • Integrating ISO 13485:2016; UDI; Technical file requirements
  • Preparing a Gap Assessment, Transitioning to MDR, and Understanding EUDAMED
Kelly Eisenhardt
Kelly Eisenhardt Co-Founder and Managing Director at BlueCircle Advisors LLC

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.

Register Now

Online using Credit card

$1,499.00

(One Dial-in One Attendee)

June 24-25, 2021, Virtual Seminar
(Registrations till June 10, 2021 - $1499)
(Registrations after June 10, 2021 - $1899)

$7,645.00

Group-Max. 10 Attendees

June 24-25, 2021, Virtual Seminar
(Registrations till June 10, 2021 - $7645)
(Registrations after June 10, 2021 - $10195)


For discounts on multiple registrations, contact customer care at +1-888-771-6965.

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Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@fdatrainingalert.com

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We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

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