This event is cancelled or expired.
Jul
2017
European Medical Device Regulations (EU MDR) - Strategic Planning for the Coming Changes
United States, Reston
11 Jul 2017 - 12 Jul 2017
Entrance: $1,300.00 (excl.VAT)
Lunch:
included
Individual Registration: $1,300.00
Multiple Company Registrants: 10% discount for three (3) or more registrants
Course overview:
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.
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.
Location:
Reston Town Center
1818 Library Street, Suite 500
Reston, VA 20190
USA
REGISTER TODAY - Limited Class Size
Click Here to Register or Visit: https://www.regonline.com/builder/site/Default.aspx?eventid=1968348
Phone: 202-822-1850
Email Us
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
Registration fee includes :
- All Training Materials
- All Resource Material
- Lunch daily
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James Pink
Vice President, Medical Devices
Instructor
Resume
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.