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EU Medical Device Regulations UPDATE
Wednesday 26 February 2020, 03:00pm - 08:00pm
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EU Medical Device Regulations

 

UPDATE


Webinar Option available

 

 

Featuring


Anthony Rizzo, Assistant VP Medical Devices Development, BSI Regulatory Services


Royth von Hahn, PhD, Senior Vice President Medical & Health Services (Global), TÜV SÜD


Nathalie Raad, Vice President of Regulatory Affairs, Applied Medical


Chris Mausch, Manager, Healthcare & Life Sciences Advisory, KPMG US

 

 

 

You are invited to an Evening Meeting


EU Medical Device Regulations

 

UPDATE Program

 


Program Synopsis


The mandatory deadline for compliance with the European Medical Devices Regulation is less than 3 months away. While hundreds of manufacturers are scrambling to get their house in order to meet these new regulations and avoid any disruption in the marketing and distribution of their medical devices, a handful of notified bodies accredited to assess manufacturers to these new regulations are at the same time scrambling to meet the assessment requirements for these new regulations. Representatives from two of the accredited notified bodies and two representatives from industry will share the challenges they have faced with implementing these new requirements. Presentations will be followed by a lively panel discussion and a question and answer period.

 

 

A webinar option will be available.

 

 

 

EU Medical Device Regulations

 

UPDATE Program

 

Wednesday, February 26, 2020, 3:00 to 8:00PM

 

Online Registration: https://www.eventbrite.com/e/eu-medical-device-regulation-update-tickets-91496006017

 

Location:


Applied Medical, 30200 Avenida de las Banderas, Building R105,
Rancho Santa Margarita, CA 92688

 

Program Host:


Anna Feng, Regulatory Affairs, Applied Medical

 

Program Managers:


Paul Kramsky, Regulatory Affairs Consultant
Gina Flores

 

Speakers, Schedule and Presentations:


3:00 - 3:30PM Registration, Networking, and Refreshments

3:30 - 3:45PM Welcome, Opening remarks
Paul Kramsky

 

Challenges with assessing manufacturers to the new rules – experience from two notified bodies

3:45 - 4:30PM:

Anthony Rizzo, BSI
• PMS/Vigilance
• Market Surveillance
• NB audits under MDR
• EUDAMED status & MDCG guidance documents update

 

4:30 - 5:15PM:

Royth von Hahn, TUV SUD
• How to prepare for May 26, 2020 for devices using the soft transition
• Art 120(3) Transitional provisions
• Economic Operators

 

5:15 - 5:45PM BREAK

 

Challenges with implementing the new rules – experience from industry

5:45 - 6:30PM:

Nathalie Raad, Applied Medical

 

6:30 - 7:15PM:

Christopher Mausch, KPMG
• EU MDR – what needs to be top of mind today
• Industry’s journey to compliance
• Lessons learned from an MDD > MDR compliance journey
• The consulting perspective on MDR – 30/60/90 days

 

7:15 - 8:00PM:

Panel Discussion and Q&A – moderated by Piet Lesage, Principal Consultant, GB5D

 

 

 

 


EU Medical Device Regulations

 

UPDATE Program

 

About the Speakers

Anthony Rizzo, Assistant VP Medical Devices Development, BSI Regulatory Services

Tony has been with BSI for 15 years. He has been a key member of the team that developed the MDSAP program at BSI as far back as 2013 and continues to be actively involved as the program evolves. Prior to joining BSI he spent six years as a consultant to international companies in automotive and medical devices focusing on personnel issues and Quality Management Systems. Tony also served eight years as president of a technical services organization in Japan, five of them overseeing other Far East regions, and 10 years in other senior management and operational positions in the inspection, testing laboratory, marine surveys and cargo supervision business. Tony holds an MS from MIT.

 

Royth v. Hahn, PhD, Senior Vice President Medical & Health Services (Global), TÜV SÜD

Royth holds M.Sc. in Physics from University of Bonn, Germany, and a degree in industrial engineering and management from the University of Applied Sciences in Koblenz (Germany). He also holds a PhD in electrical engineering from the University Duisburg in Germany. Royth started his career at the University of Bonn and a MedTech spin off/start up. He was head of a test laboratory and interim professor at the University of Applied Sciences in Koblenz. In 2007 Royth joined TÜV SÜD as Senior Product Specialist for ultrasound devices, functional safety specialist and lead auditor for active medical devices and software. He is member of several national and international standardization committees. After several assignments within the TÜV SÜD Group in global innovation management and strategic development, he re-joined the business unit Medical & Health Services in 2015 as a global Director for Functional Safety and Software. Beginning of 2016 Royth transferred from the global headquarter in Munich Germany to San Diego, to lead the North America operations of TÜV SÜD's medical device related business. Since January 2018 Royth is also heading the global business unit MHS.
Christopher Mauch, Manager, Healthcare & Life Sciences Advisory, KPMG US
Chris is a leader in KPMG’s Life Science Consulting Practice, specializing in helping his clients solve complex business problems, realize efficiencies, and navigate through difficult changes. He has amassed significant experience leading engagements across a wide range of pharmaceutical and medical device clients in the regulatory affairs, supply chain, and operations spaces, and is an active RAPS member. Prior to joining KPMG, Chris spent the first seven years of his career across multiple roles in domestic and international regulatory affairs at Abbott Laboratories in Chicago, IL.

 

Nathalie Raad, Vice President of Regulatory Affairs, Applied Medical

Nathalie Raad has over 13 years of experience in the medical device arena. She started her career as a Product R&D Engineer at Applied Medical and has been in a Regulatory Affairs role since 2011. Nathalie’s subject matter expertise lies in global regulatory affairs, design controls, risk management, usability, production and process controls, biocompatibility, and sterilization. She mentors and guides her team in support of global pre-market regulatory affairs responsibilities such as medical device submissions (including numerous Class II device 510(k) submissions), new product development, product change management as well as aspects of quality management system compliance. Nathalie enjoys systems engineering and process improvement projects, and has had numerous opportunities to apply her skills in a fast-paced, vertically integrated company that serves over 70 countries worldwide. Nathalie earned her B.S. in Mechanical Engineering with a Biomedical Specialization from Southern Methodist University in Dallas, TX.

 

 

 

EU Medical Device Regulations

 

UPDATE Program


Wednesday, February 26, 2020

 

 

ONLINE REGISTRATION INSTRUCTIONS
Registration fee includes appetizers, free parking and presentations (will be sent after the meeting if approved by the speakers to distribute).
Cost:

 

OCRA Members: $60 in-person attendance or $40 webinar* attendance


Non-Members: $135 in-person attendance or $115 webinar* attendance (includes OCRA Membership fee)


Government and Students in-person attendance: $35 for members or $70 for non-members (includes OCRA Membership fee)


Government and Students webinar attendance: $20 for members or $55 for non-members (includes OCRA Membership fee)

 

FREE for Applied Medical Employees (please register for the Free ticket option on Eventbrite)

 

If you have any questions or require additional information, email OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.).
Registration deadline is February 25th. No same day (in-person or webinar) or on-site registrations will be allowed.
You must register for this event using Eventbrite:

 

Click on this link: https://www.eventbrite.com/e/eu-medical-device-regulation-update-tickets-91496006017

 

NOTE: Some web browsers work better than others with our site. Please attempt to log on again if you cannot log on during your first attempt.

 

Non-Members: If you are not an OCRA Member, we require you to join OCRA before registering for this meeting. Your OCRA membership is included in the Non-member pricing for this program.


Multiple Registrations: Our system is set up for one registration at a time. Please register each person individually to ensure receiving information on the updates to the program. Our registration list generated through Eventbrite is used as our contact list for any program updates.

 

OCRA's non-profit Federal Tax ID# 33-0630455

 

Cancellation Deadline: For a refund, please email your cancellation request to OCRA Program Chair (This email address is being protected from spambots. You need JavaScript enabled to view it.) Feb 25, 2020.

Location Applied Medical, 30200 Avenida de las Banderas, Building R105, Rancho Santa Margarita, CA 92688
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