Europe’s Compliance Plan for Medical Devices - Webinar CD/Transcript

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Europe’s Compliance Plan for Medical Devices: Preparing for and Managing EU Notified Bodies Audits

This presentation is designed to provide medical device professionals with the information they need to prepare for and manage routine surveillance and unannounced notified body audits. You will learn the rationale, strategies and flow on how to plan for the audit, the audit process and approach, and which company roles should be assigned for notified body audits. This presentation will also show you the major changes in medical device CE certification as it relates to unannounced audits and other matters, as a result of EU Commission Recommendation 2013/473/EU. The impact this recommendation has on manufacturers, notified bodies, subcontractors, and suppliers will be explored. In addition, this presentation provides background information on notified bodies’ purpose and CE marking.

Specifically you will learn:

  • The purpose of notified body audits
  • What steps to take to become EU compliant
  • The relationship between certifications, product registrations, and ISO 13485 standard
  • The difference between a notified body, certification body, conformity assessment body and a registrar
  • The frequency of notified body audits and where to find the most current list of EU notified bodies
  • Changes and adverse events and who you should notify when they occur
  • The major changes in medical device CE Certification related to unannounced audits and other matters
  • How to prepare for a notified body audit
  • Audit process: What to expect from a notified body’s arrival up to their exit
  • The timeline to respond to notified body’s audit reports and the sequence to follow in your response

This course will be of benefit:

  • Quality auditors
  • Compliance officers
  • Executive management
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the medical device field
  • Medical device suppliers/subcontractors
  • QA/QC personnel
  • Document control personnel

Vanessa Lopez is a Senior Principal Quality, Regulatory, and Compliance Consultant. Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of quality assurance, quality control, regulatory compliance, regulatory affairs, quality systems and supplier quality activities. Ms. Lopez has in-depth knowledge and coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents.