Welcome to MDR-IVDR Training
28-29 November 2019
Lisbon, Portugal

The Medical Device Regulation and the In Vitro Diagnostic Device Medical DIrective will change significantly the way to get products to market in the European Union. It will cover as well other regulations influencing the implementation of MDR/IVDR. This event will support you to increase knowledge, to extend your network and finally make the right decisions.

About the event

Three experts will share with you the requirements to MDR and IVDR implementation and the changes to the former Directives. This training offers at the same time individual consulting sessions as needed. The training is planned for 2 days, but to make it cost effective for your company you may only book individual days as needed.

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Who should join

Representatives from Regulatory Affairs, Clinical Affairs or Quality Assurance. CEO´s, Managers or Specialist of smaller companies from international locations, but also mid-size to bigger companies may benefit from this event.

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Hot topic

Beside others we will cover with you Changes to MDR/ IVDR, Notified Body selection, working with Contract Manufacturers, Document Control System, Qualified Person, Economic Operators and responsibilities, Software Validation, Labeling and Translations, Clinical Evaluation and Clinical Evidence, Data Protection….

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Experts

The three experts together have more than 80 years of experience in Regulatory Compliance. Their goal is that all participants will be enabled to create successful strategies for a timely implementation of the new regulations.

Team Of Experts

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Dr. Petra Kaars-Wiele

Independent Consultant

Petra graduated from the University of Goettingen/Germany with Diploma in 1980 and with Ph.D. in 1983. She joined Abbott Laboratories in the same year.
Petra has more than 35 years of experience in Regulatory Affairs and Quality Systems for Medical Devices, currently responsible for all international regulatory matters, medical event reporting, risk management, managing translation for 29 languages and labeling activities at Abbott Diagnostics Division. She has experience in building Quality Management System according ISO 9001 and ISO 13485 and has passed a lead auditor training in 1997. Since then she has used that knowledge in training, setting up a QMS or consulting in that field internally and externally.
Petra is retired from Abbott since April 2019 and is working as an independent Consultant.

Other Activities include:

  • Advisor to AHWP Technical Committee
  • Chairwoman of the EDMA Globalization Working Party dealing with new and revised worldwide regulations
  • Member of the EDMA Regulatory Committee and Technical Forum
  • Past Member of the GHTF SG1, IVD Subgroup representing EDMA, from 2003 until 2012
  • Trainer activities for EU Commission, AHWP, ASEAN, APEC and USAID and WHO


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Dr. Toni Kennet Jørgensen

Founder & CEO, MDRAC GmbH

Toni studied Chemistry and software development and initiated his PhD work in South Africa in in organic chemistry, He worked in the medical device industry for 20 years, working in function responsible for compliance (Regulatory affairs, Quality Assurance and Clinical Affairs). He worked in 8 countries for company such as Johnson & Johnson and Medtronic in leading roles. In Switzerland he was the VP of Corporate Regulatory Affairs and Compliance leading a group of 50 professional experts in Regulatory Affairs.
The last 5 years he dedicated shared experience with mainly smaller start-up companies, creating clinical, regulatory and quality strategies. He supported in finding financial and human resources for companies to obtain market access to Europe and USA.
He is the founder of MDRAC a consulting service and MDRAT a training service in the medical device area. He has been a regular presenter in Europe, USA and Asia in both the industry and for regulators, such as FDA, AHWP, SGA, DIA and Informa Life Science.
With extensive knowledge to medical devices and the upcoming MDR, he looks forward to welcome you to the MDR Training event in Portugal.


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Dr. Gor Lebedev

Lead Data Scientist, Sensome

Gor received his PhD in microelectronics and signal processing from the University of Grenoble in 2012. He is a recognized expert in the field of complex data analysis and more particularly in machine learning with 8 patents to his name. Since 2015 he has been working in the field of medical devices with a strong emphasis on digital aspects such as the use of artificial intelligence algorithms in MDs, optimization of medical software development processes and software validation.
Currently Gor is working at Sensome, a French startup that develops cutting-edge technology and disruptive devices in the neurovascular field. He coordinates the digital engineering team that develops application, embedded and cloud solutions for next-generation connected medical devices. Meanwhile he has co-developed an entire document management system tailored to Sensome's needs. Thanks to his expertise in ISO 13485 and IEC 62304 he has been able to build development and validation processes that are both fast and ensure the highest quality of the final products.
Gor is very excited to be able to share his experience with you during the upcoming training.


Contact Us

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Address

DOM PEDRO LISBOA, Av. Eng. Duarte Pacheco 24, 1070-110 Lisboa, Portugal

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Call Us On

+49 1 60 92 37 74 84

email

Email us on

contact@mdr.training

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