European Medical Device Regulations (EU MDR) - Strategic Planning for the Coming Changes

Sheffield, England
Tuesday, February 20, 2018
European Medical Device Regulations (EU MDR) - Strategic Planning for the Coming Changes
Tuesday, February 20, 2018 8:30 AM -
Wednesday, February 21, 2018 4:30 PM (Eastern Time)

Hilton Sheffield Hotel
US, HS, MD, EUIVD, CR
Victoria Quays
Furnival Road
Sheffield, England S4 7YB
United Kingdom

Map and Directions

Course Description

The European regulatory landscape has changed, becoming more stringent and technically challenging for medical device companies. With major changes to notified body activities, device classification, clinical data requirements, post-market surveillance, conformity assessment and technical documentation, companies will need to plan carefully to ensure they understand the requirements and have the appropriate data, processes and resources in place.

This two-day course examines the new EU medical device regulations, outlines the major changes that industry will need to be prepared to address, and provides insight into the impact upon medical device companies and the steps they can take to navigate the new regulatory environment.

The NSF EU MDR course includes assessments to ensure that the student has achieved the knowledge and understanding to effectively plan for the new EU regulation, enabling you and your organisation to feel confident that you can implement the forthcoming changes.  This course provides a certificate of successful completion, demonstrating that your knowledge has been evaluated.

Learning Outcomes

By the end of the course you will be able to identify the major changes in the new regulation and interpret and plan the changes. Specifically you will be able to:

  • Determine if a product falls within the scope and definition of a medical device
  • Appropriately classify and outline the appropriate conformity assessment options
  • Evaluate device safety and performance characteristics and select applicable general safety and performance requirements
  • Assess the structure and content of technical documentation for submission and post-market purposes
  • Plan clinical data and post-market clinical follow-up strategies for your product portfolio
  • Review and construct appropriate legal and contractual requirements for economic operators such as distributors and authorized representatives
  • Identify post-market surveillance and vigilance requirements for your products and implement compliant feedback systems
  • Interpret and plan strategies to place product in the EU and retain compliance post-market

Who should attend?

All management, executive and regulatory personnel with direct or indirect responsibility for EU medical device CE-marking, involvement with the planning and preparation of regulatory strategy or are ultimately responsible for effectively managing the changes from the medical device directives to the medical device regulation.

Instructor Information:

James Pink, Vice President Medical Devices

James has over 20 years of experience in the medical devices industry including 10 years as a Heath Care Technology Expert and Lead Auditor for a leading European Notified body. His industry experience includes managing development and quality assurance programs for Orthopaedic, Cardiovascular, Wound and Combination products.

James has coordinated and presented to EU competent authorities and expert working groups relating to classification decisions, clinical study design, scientific and technical briefings and has spent a number of years participating in industry and regulatory agency working groups preparing for and evaluating the impact of the proposed text and framework of the new EU regulation.

Location: Sheffield, UK (Exact location TBD)


Cancellation Policy

Cancellations will be accepted up to 30 days prior to the training course, subject to a 10% cancellation fee. Student substitutions will be accepted until the course start date.

 

Contact Information

Payment Instructions

  • Registration Cost:

    • Individual Registrant- $1,400.00 USD
    • Multiple Company Registrants- 10% discount for three (3) or more registrants

    Registration Fee Includes:

    • All Training Materials
    • Resource Material
    • Lunch daily

    Payment Methods:

    • Major credit card
    • Invoice
      • Please note: payment in full will be needed 7 business days prior to the start of the course if paying via invoice
      • If paying via invoice, all "bill to" information must be filled out. 
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