Software and Digital Health under EU MDR Webinar
A Virtual Event
September 16, 2020

Software and Digital Health under EU MDR

 

Even companies that are successfully managing other aspects of EU MDR still wrestle with the challenges of software.  Most software currently in Class I will be upclassified, requiring the establishment of a certified quality system and notified body involvement.  There is confusion about current and evolving device and system standards and guidances and their relationship to the new regulatory requirements, and significant ambiguity about emerging technologies, cybersecurity, data privacy, interoperability, and risk management.


Join MedTech Intelligence for a roundtable discussion in which experts from industry, notified bodies, and consulting firms have identified the challenges and established procedures for managing them.

Add to the discussion by submitting your own questions in advance or during the webinar.



Discussion Topics Include:


·      The challenges with software cybersecurity, risk management, artificial intelligence, & digital health

o   Existing undefined issues

o   New undefined issues

o   Emerging undefined issues

·      Key changes under EU MDR

·      What software is or is not covered under the new regulations

·      New classification and upclassification of software

·      Alignment between EU MDR, IMDRF, FDA, and other international guidances and standards on health software and IT systems and cybersecurity

·      Evolving approaches to newer technologies, e.g. AI and machine learning

·      Interoperability



Who should attend:

·      Software engineers

·      RA/QA

·      Risk management

·      Standards experts

·      Postmarket surveillance



Visit www.medtechintelligence.com

Agenda
Wednesday, September 9
12:00 PM - 12:05 PM
12:00 PM - 12:05 PM
12:05 PM - 1:20 PM
12:05 PM - 1:20 PM
1:20 PM - 1:30 PM
1:20 PM - 1:30 PM
Speakers
CEO
Springborne Life Sciences
Chief Innovation Architect
Underwriters Laboratory
Principal Engineer
Regulatory & Quality Solutions
Global Director, Functional Safety
TUV SUD

FREQUENTLY ASKED QUESTIONS

What are the registration prices:

Medical Technology Organization:

  • Early bird registration is $95 - Available until Aug. 16, 2020
  • Regular Registration is $125 - Available between Aug. 16- Sept. 4, 2020
  • Late Registration is $150 - After Sept. 4, 2020

Group Registrations:

If you register a group of more than 2 registrations at the same time, each registration after the 1st receives a 50% discount. Remember, in order to receive this discount, registrations MUST BE MADE AT THE SAME TIME. There will be no retroactive refunds of registration fees. 

How do I log in to the event?

  • You will receive an email with a link to GotoWebinar with instructions how to log into the live event by Sept. 14, 2020.  Please note that this will be a live event.

Can I ask questions of the speakers?

  • Yes! You will be able to type your questions into a chat dialog box and the moderator will read it out loud to the speakers.

What happens if I miss the event:

  • There are no refunds or cancellations within 7 business days of the starting date of the event.

Cancellation and Refund Policy:

  • All cancellations must be made via email. Should you not be able to attend the virtual event, you may have someone else from your organization take your place or use your registration fee as credit towards a future MedTech event. If these options are not possible, you can receive a refund of the registration fee less a 20% processing fee up until 7 business days prior to the virtual event. There are no refunds for cancellations within the 7 day period prior to the virtual event or for "no-shows" to the virtual event.