Postmarket Surveillance and Postmarket Clinical Follow-Up Webinar
A Virtual Event
September 09, 2020

Postmarket Surveillance and Postmarket Clinical Follow-Up

 

Some of the most challenging aspects of EU MDR are the requirements for postmarket activities. 

  • How do you maintain compliance in a complex and dynamic environment? 
  • How does a company shift to active surveillance, generate and review all of the necessary reports, and establish the infrastructure to support these procedures? 
  • What is “sufficient” evidence in post-market clinical follow-up (PMCF), and how does one collect data for the life of products, particularly legacy or low risk devices? 
  • What are best practices for the summary of safety and clinical performance (SSCP) and periodic safety update reports (PSUR)?

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:


MDR requirements for a postmarket surveillance system (PMS)

Creating a PMS plan and organizational structures to support it

Postmarket reports

Clinical evidence requirements; defining “sufficient clinical evidence

Updating Clinical Evaluation Reports (CER)

Postmarket Clinical Follow-Up (PMCF)

Data reported to EUDAMED and its use

Remediation of legacy devices

Notified body audit observations 



Who should attend:

·      Regulatory/Quality

·      Clinical

·      Postmarket surveillance

·      Risk management

·      Auditors



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
Director, Medical & Clinical Affairs
Abbott Quality & Regulatory
VP, EU MDR & IVDR Consulting Services
Regulatory & Quality Solutions
Head, Medical Affairs Monitoring & Analytics
Philips Healthcare
Senior Director, Quality & Compliance
Baxter Healthcare
International Regulatory Manager
3M Health Care
CEO & Co-Owner
Qunique GmbH
Clinical Reviewer
TUV SUD Product Service GmbH

FREQUENTLY ASKED QUESTIONS

What are the registration prices:

Medical Technology Organization:

  • Early bird registration is $95 - Available until Aug. 3, 2020
  • Regular Registration is $125 - Available between Aug. 4- Aug. 24, 2020
  • Late Registration is $150 - After Aug. 24, 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. 1, 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.