Understanding CE Marking Requirements / Roadmap to Expedite CE Marking

Duration: 60 Min
Parul Chansoria
Parul Chansoria Founder, Elexes Medical Consulting

Parul Chansoria is the Founder of Elexes, and a Regulatory consultant who is RAC certified by RAPS, CQA certified by ASQ, certified Lead Auditor for ISO 13485:2016 by BSI and ICH GCP certified. She has prepared several 510(k) submissions, pre-submissions, technical files for CE, design dossier, etc., advised companies on preparing for CMDCAS, ISO 13485 and country-specific GMP certifications, and reviewed clinical study protocols for medical devices as per ISO 14155. She has a Master’s Degree in Bioengineering from the University of Illinois. Parul has worked as an Electrophysiology Researcher at UIC, Chicago, and has served many companies like Stryker, OSI, and Intuitive Surgical. She has an overall of 10 years of experience and works in the capacity of Director to many medical device companies.

CE mark is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the health, safety, performance, and environmental protection legislations for medical devices within the EFTA and European Union (EU). The CE mark is a legal requirement to introduce a medical device within the EFTA and EU market.

Why Should You Attend:

CE mark is the gateway to sales in EU. Several factors play an important role in getting a CE mark quickly, most important of all being how complete, consistent and thorough are your documents when submitted to regulatory bodies, and if they are written such that they preemptively address any questions from the Notified Body (NB).

During this session, we will cover:

  • An excellent understanding of the CE Marking
  • Knowing how it might impact your product
  • A clear understanding of your potential next steps
  • Practical tips and guidance for actual implementation

Areas Covered in the Webinar:

  • Steps to obtain a CE Mark
  • How should your project plan for a successful CE Mark look like?
  • What pitfalls to be aware of?
  • Few Case Studies of failed CE Mark and why?

Who Will Benefit:

This webinar will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU.

  • Clinical research and medical operations
  • Project Managers
  • Design Engineer
  • Product Development personnel
  • Manufacturing personnel
  • Researchers managing Medical Device R&D and Development
  • Quality Assurance such as GMP, GCP Auditors
  • Regulatory affairs
  • Clinical trial supply personnel
  • CRO personnel
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