Navigating New ISO 13485 Quality Assurance and EU Device Regulations

Original Recording Date: 
June 15, 2017
Length: 
1.5 hours
Registration Fee: 
$99 per person

Register for the webinar replay.

Important changes have been made to ISO 13485, which defines quality assurance of medical devices.Get the latest regulatory update as well as a deeper dive into the most recent changes for dental manufacturers and suppliers selling medical devices inside the European Union. Learn about these important new requirements and the effect of Brexit for those that sell in the United Kingdom.

The Navigating New ISO 13485 Quality Assurance and EU Device Regulations webinar is a must-attend event for any DTA member company’s regulatory personnel and DTA member manufacturers with quality assurance certification who are now selling their devices in Europe or plan to in the future. Also, executives at small DTA member manufacturing companies will find the information valuable. During the webinar, attendees will learn about: 

  • Adopted changes to ISO 13485 and specific areas that manufacturers and distributors need to pay careful attention to.
  • Details about regulatory changes for selling devices in Europe.
  • Important changes in quality assurance systems  allowing manufacturers and suppliers to become certified to sell their devices in the U.S., Canada, Europe and throughout the world.
  • New EU device regulations that must be adopted before 2020 for companies planning to sell their devices inside the European Union.

 

About the Presenters: 

Grant Ramaley

Grant Ramaley is Director of Regulatory Affairs for Aseptico Inc., a manufacturer and marketer of dental support equipment in the United States and Canada since 1975.  Ramaley is co-chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, Convener for the ISO 13485 Working Group at the International Accreditation Forum, and Technical Committee Advisor to the Asian Harmonization Working Party. Grant is well versed in ISO and Quality Assurance practices for the medical device community.