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Hybrid Event, 20 - 24 June 2022
In-Person: Dublin, IrelandDigital Experience: One track will be live-streamed
each day in GMT time zone, with on-demand recording access for all other tracks
made available on the afternoon of the following day. Learn more on the Digital
Experience page.
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Hybrid Event, 20 - 24 June 2022
In-Person: Dublin, IrelandDigital Experience: One track will be live-streamed
each day in GMT time zone, with on-demand recording access for all other tracks
made available on the afternoon of the following day. Learn more on the Digital
Experience page.


Hybrid Event, 20 - 24 June 2022
In-Person: Dublin, Ireland,
Digital Experience: One track will be live-streamed each day in GMT time zone,
with on-demand recording access for all other tracks made available on the
afternoon of the following day. Learn more on the Digital Experience page.


HOW ROBUST IS YOUR PMS STRATEGY?


GET CLARITY ON THE PMS REQUIREMENTS WITH GUIDANCE ON PSUR, QMS & PMCF METHODS
FROM COMPETENT AUTHORITIES, NOTIFIED BODIES AND PEER-TO-PEER SHARING.

Including focused insights on risk management, state-of-the-art, ISO 13485, and
more!
See The PMS Agenda



ADVANCE YOUR PMS & VIGILANCE SYSTEMS WITH PRACTICAL TIPS




COMPETENT AUTHORITY AND NOTIFIED BODY UPDATES ON PMS

 * Competent Authority guidance on PMS requirements and expectations
 * Post Market Surveillance Plans Under the EU MDR: Notified Body Feedback
 * QMS audits: Hear a Notified Body perspective


CASE STUDIES: APPLYING THE PMS REQUIREMENTS

 * Gain practical tips on how to statistically justify the evaluation of your
   PMS plans
 * Implementation insights on enabling risk control throughout the device
   lifecycle
 * Understand the data flow requirements for a successful Quality Management
   System (QMS) under ISO 13485
 * Learn how companies are constructing their Periodic Safety Update Reports
   (PSURs): State of the Art (SotA), benefit vs risk, and contents


INTERACTIVE POST MARKET PANEL DISCUSSIONS

 * Experiences creating and maintaining a robust Post Market Surveillance plan
   including early adopter feedback, proactive PMS, workload, timelines and
   lessons learnt
 * Fireside chat: Explore how real world data and evidence can be used
   successfully to support PMCF
 * Gain an update on the status of Annex XVI from TUV SUD and Croma - Pharma

See the PMS agenda


EMBRACE POST MARKET SURVEILLANCE BEST PRACTICE WITH INSIGHTS FROM THE EXPERTS


RIKKE LEWINSKY

SENIOR CLINICAL SURVEILLANCE SCIENTIST

RADIOMETER MEDICAL


JEFFREY CYR

SENIOR MANAGER, REGULATORY AFFAIRS

SIRTEX


MATTHIAS FINK

MANAGER CLINICAL FOCUS TEAM NORTH AMERICA

TÜV SÜD PRODUCT SERVICE GMBH


RIKKE LEWINSKY

SENIOR CLINICAL SURVEILLANCE SCIENTIST

RADIOMETER MEDICAL

Meet the PMS Speakers


ELSEWHERE AT MEDTECH SUMMIT




#MedTech
 * MedTechIC
 * MedTech: Regulation & Strategy
 * MedTech Summit
 * Medical Device Regulatory Affairs

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