FDA & International Consulting and Training Services
CE Marking: Medical Devices, IVDs & AIMDs 2017
Date: Thursday, July 13, 2017
Location: Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA
All medical devices and IVDs must have a CE Mark in order to be sold in the European Union. And, the rules for CE marking these devices are changing. This course will delve into the details of CE Marking medical devices, active implantables, and IVDs. Topics such as product classification, Technical File construction, authorized representatives, Notified Body selection/audits, directives, & the pending regulations will be reviewed. Special focus will be given to the timing of moving from the directives to the regulations, technical file / design dossier construction including selection of standards and how to ensure that the file continues to reflect the current state of the product while providing insight into how to remain current with the ever-changing landscape of standards, guidance documents and emerging rules that may impact your product. This course will help you develop documentation that clearly shows a product complies with the directive/regulation and supports the CE mark. It will be of interest to companies that are looking to CE Mark new products and those wishing to maintain their CE Mark and compliance. The course will be of interest to staff involved in CE Mark approvals, related documentation processes and ISO 13485 compliance programs (also see Wednesday's ISO 13485 course).
What you will learn:
- The CE Mark approval process for medical devices, active implantables & IVDs.
- The roles of all parties involved: Competent Authority, the new MDCG, Notified Body, authorized representative, manufacturer, importer, and distributor.
- Directives currently in effect as well as the pending regulations, how to achieve compliance & plan the move to the new regulations.
- How to classify your Medical Device or IVD and what are “routes to conformity”.
- How to create technical files & dossiers that Notified Bodies will accept.
- How to document and show compliance to Essential Requirements.
- Standards & guidance to use in demonstrating compliance.
- Use of Common Technical Specifications (CTS).
- Electronic IFU Rules – can you avoid printing? What Languages are required.
- Latest information on the new medical device & IVD regulations.
- Timing and schedule planning.
Benefits of Attending:
- Learn the requirements for CE Marking devices & IVDs.
- Access the European Community.
- Hear up to date information on directives and CE Mark processes.
- See how standards fit into the technical documentation.
- Determine the best route to conformity for your situation.
- Prevent delays during the approval process.
- Stay ahead of or keep up with your competitors.
- Understand the relationship between CE Marking and ISO 13485.
- A. CE Mark Overview
- B. Classification & Conformity Assessment Routes
- C. Creating a Technical File / Design Dossier
- D. Understanding and Meeting the Essential Requirements
- E. The Notified Body Audit
(beware of the unannounced audit program)
- F. Guidance Documents (including vigilance)
- G. Maintaining Technical Files / Design Dossiers
- H. Overview of Other Directives to Consider
- I. Update on the proposed amendments to the regulations/directives.
- J. Review and Summary
Speakers: Christine Ruther, Deborah Madsen
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