CE Mark for Exports to Europe – Webinar

Hosted by the Alabama International Trade Center, the Alabama Department of Commerce, and the US Commercial Service

Registration Link:

https://asbdc.ecenterdirect.com/events/8726

Agenda:

• Export Alabama Alliance /AITC Introduction
• BSI Group
• • What is the CE Mark and how do companies get CE Mark approval
  • Which countries/industries require the CE Mark
  • • With more focus on biotech/life science/medical device industries
  • Brief update on UK Brexit and if that affects CE Mark process for sales to the UK
• US Foreign Commercial Service Resources for the CE Mark approval process
• ADOC Alabama STEP Grant program for the CE Mark

BSI, Regulatory Services, Medical Devices:

BSI is a trusted, world-class Notified Body and Conformity Assessment Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers around the world.

BSI Medical Devices has a team of over 700. Within that team are our technical experts with experience encompassing the full range of medical devices and management system standards. Our services include system certification to ISO 13485, CE marking, product testing, and standardization to support your global market access goals.

BSI has two Notified Bodies, one in the UK (0086) and one in the Netherlands (2797), both of which have full scope designations to the IVDR and MDR.

Our presenter will be Bill Enos:

Bill Enos is the Senior Commercial Director, Medical Devices – Americas and has been with BSI for more than 15 years. Bill is now responsible for leading BSI activities in the medical devices regulatory sector for the Americas region including EU Notified Body, ISO 13485 Certification, Health Canada / SCC CMDCAS accreditation and MDSAP Auditing Organization recognition. Previously Bill was the Global Head of Microbiology at BSI. His responsibilities included auditing quality systems and review of technical files and other certification activities related to sterile medical devices. Before joining BSI, Bill was vice president for technical sales and business development at Microtest Laboratories, where he was involved with all aspects of medical device, pharmaceutical testing and manufacturing.