ALL UPCOMING Events/Webinars

September 6, 2017 | Wiener Neustadt, Österreich

UL SEMINAR FÜR MEDIZINPRODUKTE IN WIENER NEUSTADT – MATERIALCHARAKTERISIERUNG; VALIDIERUNG VON VERPACKUNGSPROZESSEN; REINIGUNGS-, DESINFEKTIONS- UND STERILISATIONSVALIDIERUNG;

SEMINAR FÜR MEDIZINPRODUKTE IN WIENER NEUSTADT MATERIALCHARAKTERISIERUNG VALIDIERUNG VON VERPACKUNGSPROZESSEN REINIGUNGS-, DESINFEKTIONS- UND STERILISATIONSVALIDIERUNG” Wir hoffen, dass Sie an diesem Seminar für Medizinprodukte teilnehmen können. Wo: ACMIT Gmbh, Viktor Kaplan Straße 2/1 Gebäude A, A-2700 Wiener Neustadt, Österreich Wann: Mittwoch, 06. September 2017, 16:00 – 20:00 Uhr Die Zulassung von Medizinprodukten stellt die Hersteller immer… read more

September 12, 2017 | National Harbor at the DC Waterfront

RAPS Regulatory Convergence: “EU IVDR: Classifications/Performance Evaluation”

12 September 2017: UL regulatory expert, Sue Spencer speaking on “EU IVDR: Classifications/Performance Evaluation” from 8:30-10:00 am. Description/Outline of Proposal: Under the new IVD regulations we will see a quantum leap, currently only 20% of manufacturers needing a Notified Body in the future at least 80% will need a Notified Body. As a result there… read more

September 12, 2017 | Online

UL Live Webinar: Writing HFE Reports for Submission to FDA

Since the late 1990s, FDA has expected Class II and III medical device manufacturers to apply human factors engineering (HFE) comprehensively to help reduce the chance of harm due to use errors. In 2016, FDA updated its HFE guidance to industry, specifying that submissions should include an HFE Report if the associated device requires users… read more

September 20, 2017 | Radisson blu Hotel, Zürich-Airport

UL SEMINAR FÜR MEDIZINPRODUKTE IN ZÜRICH – MATERIALCHARAKTERISIERUNG; GEBRAUCHSTAUGLICHKEIT / USABILITY / HUMAN FACTORS ENGINEERING (Vortrag in Englischer Sprache)

September 26, 2017 | Online

UL Live Webinar: Writing HFE Reports for Submission to FDA

October 12, 2017 | Online

UL Live Webinar: Deep Dive into the impact of the changes to the EU Medical Device Regulations – A Notified Body Point of View

November 7, 2017 | Online

UL Live Webinar: How to prepare for new EU MDR Requirements for Clinical Evaluation and Technical Documentation – A Notified Body perspective