ComplianceOnline, Virtual Training Through WebEx
2021-07-12
DAY 01(10:00 AM - 6:00 PM EDT)
10:00 am – 11:30 am
What are the new topics in the EU MDR 745/2017 (Summary) A brief summary of the new topics to get an overview about the MDR. The focus is performance and safety. Both need to be approved by verification and validation actions in pre-clinical activities (physically, chemically and biologically lab tests) and in clinical study activities or clinical evaluations. The risk classes and the regulatory pathway for high risk products changed.
11:30 am – 11:45 am Coffee Break
11:45 am – 12:30 pm
How to create a clinical evaluation compliant to the EU MDR 745/2017 and the expectations of auditors .The MEDDEV 2.7.1 rev. 4 was implemented into the MDR and is strong related to the pos market activities and PMCF activities. In which cases is a PMCF study required and what are the expectations of a reviewer / auditor and what are the major changes?
15:00 pm – 15:15 pm Coffee Break
15:15 pm – 16:45 pm
The post market surveillance and post market clinical follow up activities and the expectations.The MDR requires frequently reporting’s to Notified Bodies and Authorities about safety and performance of the medical devices. How to create the reports.
DAY 02(10:00 AM - 6:00 PM EDT)
10:00 am– 11:30 am
The EN ISO 13485:2016 clause 0 – 4 requirements and expectations of an auditor. The new ISO standard received a couple of updates and focus now more on regulatory Requirements from local regulations e.g. the EU MDR 745/2017. What are the updates and changes clause by clause. What are the expectations of an auditor?
11:30 am – 11:45 am Coffee Break
11:45 am – 12:30 pm
The EN ISO 13485:2016 clause 5 – 8 requirements and expectations of an auditor. The new ISO standard received a couple of updates and focus now more on regulatory Requirements from local regulations e.g. the EU MDR 745/2017. What are the updates and changes clause by clause. What are the expectations of an auditor?
12:30 pm – 13:30 pm Lunch
13:30 pm – 15:00 pm
The interfaces between EN ISO 13485:2016 clause 0 – 4 and EU MDR 745/201 The EN ISO 13485 references 37 times the MDR. How to understand the references and what are the required activities according the standard and the MDR. What are the expectations of an auditor?
15:00 pm – 15:15 pm Coffee Break
15:15 pm – 16:45 pm
The interfaces between EN ISO 13485:2016 clause 5 - 8 and EU MDR 745/2016 The EN ISO 13485 references 37 times the MDR. How to understand the references and what are the required activities according the standard and the MDR.
Organized by:
ComplianceOnline
Invited Speakers:
Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.
Deadline for Abstracts:
2021-07-11
Registration:
$1,699*
(Seminar for One Registration) July 12-13, 2021, Virtual Seminar