Tatsiana RipichHead of Regulatory Affairs at enmodes GmbHSpeaker
Profile
Tatsiana holds 9+ working experience in the Medical Device Industry, including National Authority, big and small medical devices manufacturers, covering different medical devices from class 1 to class 3 (wound care products, implants, cardio-pulmonary) and different QA&RA roles with experience in establishing and certifying quality management system, in regulatory approval of medical devices world-wide, regulatory product development, vigilance etc.
She is leading a multi-disciplinary team of QM&RA managers
Tatsiana holds a PhD Degree in Biology (Stem cells) and RAC Certification Medical Devices
Agenda Sessions
SME Survival Guide - Introduction
, 11:05View SessionQMS under MDR: SME Successes, Failures & Fast Fixes
, 12:30View SessionQMS Priority Sprint: Build Your MDR Evidence Map
, 12:50View SessionGroup Activity 3: PMCF strategies and Real World Evidence
, 15:20View SessionAsk The Experts Open Q&A
, 17:30View SessionLegacy Devices in Focus: Leveraging Clinical Evidence and PMS Strategy for 2027 Compliance
, 10:20View Session