TÜV SÜD embarked on a six-stop North American roadshow in August 2016 to join industry leaders in discussion and lectures regarding the new regulations on CE marking approval in Europe and the impact on CE marking. The flagship event kicked off on August 2 in Boston, Massachusetts, followed by Tampa, Florida, on August 3, Minneapolis, Minnesota, on August 5, and Toronto, Canada, on August 8, then moving West to California locations Irvine and San Diego on August 10 and August 11 respectively.
The shows featured TÜV SÜD experts Dr. Bassil Akra and Dr. Royth von Hahn, two leading authorities on medical device regulations and a number of health care and medical fields. The two were on hand to provide technical expertise on the new EU regulatory changes that will impact medical device manufacturers and answered attendees’ questions. Additionally, the events provided a valuable half-day information and networking session, which was RAC-approved.
The European CE marking rule changes have been a source of constant dialog and scrutiny in the regulatory community and among device manufacturers for several months. To shed some light on the changes – insight on what they mean for manufacturers and regulatory procedures, and what’s next for the industry – Dr. Basil Akra, TÜV SÜD’s global director of the Clinical Center of Excellence, and Dr. Royth von Hahn, vice-president of TÜV SÜD America’s Medical and Health Services, conducted a joint webinar.