Understand the key changes of Europe's new Medical Devices Regulations (MDR) that is impacting the healthcare industry from the Medical Device Directive (MDD) from renowned DNV GL Lead Auditor and MDD Assessor, Mr Hasan Zarin Mehr as he addresses the hottest topics on every healthcare practitioner's mind.
MDR (Medical Device Regulation) - Key Changes and Time Lines
Date: Tuesday April 9 2019
Time: 12.45pm - 2.00pm
Speaker: Mr Hasan Zarin Mehr (ISO 13485:2016 & ISO 9001:2015 Lead Auditor, MDD/MDR Assessor, Qualified Auditor of MDA)
Who should attend: Medical Device Manufacturers and relevant persons in-charge including Top Managements, CEO, Regulatory Affairs (RA), Quality Management Representative (QMR), Quality Assurance (QA), all persons involved in providing Technical file/Documentation, Clinical Evaluators, Consultants in Medical Device industries. Medical Device companies who have plan for manufacturing and obtain the CE mark.
In this Seminar, we will focus on key changes of MDR, Transition Period and Annexes of MDR.
New changes including
-Market Access of Legacy Products
-Reprocessing of Single Use Devices
-Vigilance and Post Market Surveillance (PMS)
-Mandatory Product Liability Insurance