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Clinical Evaluation Reports Compliance with MEDDEV 2.7.1, Rev 4/ MDR sponsored by NEDG

NEDG, part of ASQ Biomedical Division

Wednesday, February 27, 2019 from 4:00 PM to 8:00 PM (EST)

Clinical Evaluation Reports Compliance with MEDDEV...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Early Bird Registered Attendee
Register before 31 Jan 2019
Jan 31, 2019 $125.00 $0.00
Group Discount (same company), Early bird
This for groups of attendees, 4 or more, from the same company. Refunds which reduce the attendees below 4 will be $0 for the 4th attendee. 1-3 will be $125 each.
Jan 31, 2019 $100.00 $0.00
Student
Please have Student ID available the day of the event
Feb 27, 2019 $100.00 $0.00

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Event Details

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Clinical Evaluation Reports

Compliance with MEDDEV 2.7.1, Rev 4/ MDR

Keynote Speaker Dr. Ibim Tariah, BSI 

February 27, 2019

4:00-8:00pm (check in time 3:30pm)

Waltham Woods Corporate Center

860 Winter Street, Waltham, MA 02451

 What will you learn?

1. Key aspects of MEDEV 2.7.1, Rev. 4 and MDR Requirements

2. How to comply with the Regulations

  • What to include in a Clinical Evaluation Plan
  • What to include in a Clinical Evaluation Report
  • How to demonstrate "State of the Art"
  • How to demonstrate sufficient clinical evidence

3. Real world examples/challenges

  • Definition of equivalence / What if you are not equivalent?
  • How to incorporate PMS data / other creative solutions
  • Risk/Benefit Assessment - Importance of Medical Perspective
  • When a PMCF / Clinical Study is needed

Cost:

Register by January 31, 2019- $125.00

After January 31, 2019, - $150.00

Refunds can be issued up to 7 days before the event.

Register on line Using EventBrite (Google: EventBrite CER workshop)

For more information contact the Program Chair: Sue Finneran

sue.finneran@gmail.com, 781-664-0074

* Save the Date! 12 Mar 2019: Software Validation: How to Survive! https://www.eventbrite.com/e/nedg-software-validation-how-to-survive-tickets-54760540250

Ibrim Tariah

Dr. Ibim Tariah is the Technical Director for BSI Healthcare. He earned his PhD in Materials Science with emphasis on polymer science and technology from the University of Manchester, U.K. Dr. Tariah has over 25 years of experience in the medical device industry in which he led global organizations in successful product development, project management and provided technical expertise in support of commercial efforts. In the years, since coming to BSI, Dr. Tariah has been providing expertise in vascular, orthopedic & dental and other long term implantable devices for clients needing technical documentation assessment and reviews in compliance with the Medical Device Directive (MDD) and development & delivery of specialized MDD training courses

Jasmine Hunter

 

Jasmin Hunter is a Clinical and Regulatory Affairs Consultant at Qserve. She earned a BSc in Microbiology from the University of New Hampshire and a Technical Writing certificate from Middlesex Community College. Prior to her transition into the regulatory aspects of medical device development, she worked in the pre-clinical research sector developing reagents to study disease progression and treatment progress in lung cancer and various hematological malignancies. Today, she has over seven years of experience designing and implementing Clinical Evaluation strategies for CE certifications for a variety of medical devices. Since joining Qserve, she has delivered specialized training workshops on how to successfully perform clinical evaluations with cross-functional teams at client locations.

 

Bonnie Weiner 

Dr. Bonnie H. Weiner is the Senior Medical Director at Boston Biomedical Associates. She received her BA from Mills College in Oakland, California (1970) and her MD from the University of Oregon Medical School (1974). She has since received Masters of Science in E-Commerce and MBA degrees (2003, 2004). In 2015 she completed a certificate program in Health Economics and Outcomes Research. Over the course of her 40 year career in both academic and clinical medicine, Dr. Weiner has been the Principal Investigator for many industry and government sponsored research activities for pharmaceuticals, medical devices and connected health. She has also been instrumental in the design and execution of clinical trials leading to regulatory approvals. Her focus in these areas has been in the acquisition and analysis of quality data that can be used to improve patient outcomes, understanding risk/benefit relationships and patient preferences. This has also translated to the planning and writing of CERs for medical devices and combination products used in many disease states.

Have questions about Clinical Evaluation Reports Compliance with MEDDEV 2.7.1, Rev 4/ MDR sponsored by NEDG? Contact NEDG, part of ASQ Biomedical Division

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When & Where


Waltham Woods Conference Center
860 Winter St
Waltham, MA 02451

Wednesday, February 27, 2019 from 4:00 PM to 8:00 PM (EST)


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Organizer

NEDG, part of ASQ Biomedical Division

§The Biomedical Division is an industry specific Division of ASQ
§ 
Our Vision 
To be the leading authority on quality issues related to the Biomedical Community
 
Our Mission 
To promote the awareness and the use of quality principles, concepts and technologies in the Biomedical Community
 

 

 

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