Fundamentals of EU MDR and IVDR – Level 1: 2-Day In-Person Seminar

By: Kelly Eisenhardt, Co-Founder and Managing Director at BlueCircle Advisors LLC
Location :- Minneapolis, MN | Thursday, January 30, 2020 | Friday, January 31, 2020

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Course Description:

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

Areas Covered:

Topics covered in this seminar include:

  • Objectives of the medical device regulation
  • Directives replaced with regulation
  • Risk based device classification
  • Conformity assessment and its relevant changes (Annex IX, Annex X, Annex XI)
  • Requirements for technical documentation found in GSPR Annex 1
  • UDI and traceability requirements, responsibilities, and impacts (EUDAMED)
  • Process for clinical evaluations
  • Clinical evidence with supported documentation
  • Post market requirements (Annex XIV and Annex 3 Part B)
  • Audit management and Notified Bodies requirements for manufacturers, as well as internal audit impact (Article 51, Annex V111)
  • Impact on the Quality Management System

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

Course Outline

Day One (8:30 AM – 5:00 PM)
  • 08:30 AM - 09:00 AM - Registration
  • 9:00 AM - 10:00 AM - Introduction/review of Medical Device Regulation and timeline
  • 10:00 AM - 10:15 AM - Break
  • 10:15 AM - 12:00 PM – Differences between the old and new version (MDD/MDR)
  • 12:00 PM - 1:00 PM - Lunch
  • 1:00 PM - 3:00 PM – Lifecycle of a Device, Process pre and post market
  • 3:00 PM - 3:15 PM - Break
  • 3:15 PM - 5:00 PM - Transitioning to the new requirements
  • Day Two (8:30 AM – 4:00 PM)
  • 8:30 AM - 9:00 AM - Registration and Break
  • 9:00 AM - 10:00 AM – Compliance procedures and Quality Management Systems
  • 10:00 AM - 10:15 AM - Break
  • 10:15 AM - 12:00 PM – General safety and performance (GSPR) and Common Specifications (CS)
  • 12:00 PM - 1:00 PM - Lunch
  • 1:00 PM - 2:00 PM – Integrating ISO 13485:2016; UDI; Technical file requirements
  • 2:00 PM - 2:15 PM – Break
  • 2:15 PM – 5:00 PM – Preparing a Gap Assessment, Transitioning to MDR, and Understanding EUDAMED
  • Meet Your Instructor

    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.

    Venue

    Location :
    Minneapolis, MN (Venue to be announced shortly)

    January 30-31, 2020
    Register Online

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    $1,499

    Seminar One Registration

    January 30-31, 2020, Minneapolis, MN
    (Registrations till November 25, 2019 - $1499)
    (Registrations after November 25, 2019 - $1899)

    Your registration fee includes the workshop, all course materials and lunch.
    For discounts on multiple registrations, contact customer care at +1-1-888-771-6965.

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