FDAnews Announces — Medical Device Clinical Evaluation Reports: Complying with European Guidelines and the New MEDDEV 2.7/1 Rev. 4 Guidance Webinar, April 4, 2017

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The main challenge for device companies in developing a Clinical Evaluation Report (CER) is making the justification that the available data is sufficient to support the safety and performance of a device. Join Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — on April 4 when she’ll discuss the requirements for CERs and their place in supporting new device certification and maintaining certification.

Medical Device Clinical Evaluation Reports: Complying with European Guidelines and the New MEDDEV 2.7/1 Rev. 4 Guidance
**An FDAnews Webinar**
April 4, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdclineval                

How will the new EU MDR language change the way manufacturers approach CERs?

One of the provisions in the new EU MDR restricts the types of clinical data manufacturers can use in CERs.

Join Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — on April 4 when she’ll discuss the requirements for CERs and their place in supporting new device certification and maintaining certification. She will cover best practices for completing CERs, complying with regulations including the MEDDEV 27/1 Rev 4 guidance.

This 90-minute webinar will cover:

  • What is sufficient clinical data
  • The components of a CER
  • Expectations of the notified body assessors as they relate to CERs

Register today and establish a process for strategizing and executing CERs.

Meet the Presenter:
Michelle McDonough, Associate Director, Regulatory & Clinical Affairs at Musculoskeletal Clinical & Regulatory Advisers

Michelle McDonough joined MCRA in January 2009 and is responsible for drafting, reviewing, and strategizing US and international regulatory submissions including 510(k)s, PMAs, IDEs, Pre-Submissions, Technical Files, and Clinical Evaluation Reports, as well as, the management, design, and implementation of pre- and post-market clinical studies. Additionally, Michelle reviews company design history files, labeling, and clinical protocols for regulatory compliance, performs due diligence reviews of devices, designs and reviews pre-clinical and animal testing for device companies, develops initial and continuing review submissions for IRB approval, and oversees data management of clinical projects.

Who Will Benefit:

  • Medical Device Presidents and CEOs
  • Regulatory Affairs Management
  • Clinical Affairs Management
  • R&D Management

Webinar Details:
Medical Device Clinical Evaluation Reports: Complying with European Guidelines and the New MEDDEV 2.7/1 Rev. 4 Guidance
**An FDAnews Webinar**
April 4, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdclineval            

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/mdclineval                                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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