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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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FREE ON-DEMAND WEBINAR
September 19, 2024

Key Considerations for Implementing Post-Market Clinical Follow-Up for Medical Devices

A clinical evaluation has to demonstrate compliance with the General Safety and Performance Requirements of the EU MDR before the device can be placed on the market.

In the post-market phase, it is mandatory to continuously update the clinical evaluation. This is called post-market clinical follow-up (PMCF) and it is done by pro-actively gathering clinical data that originates from the use of the device.

The European Medical Device Regulation (MDR) introduced the concept of PMCF to ensure ongoing safety and performance of medical devices throughout their entire life cycle, especially after they have entered the market.

PMCF always includes a regular and adequate collection of up-to-date data but might also have to include targeted activities to improve limited data sets. The need for this data is identified in the clinical evaluation and the PMCF plan translates it into endpoints and activities of data generation.

The focus of this webinar is then to help medical device manufacturers establish an effective post-market clinical follow-up.

Specifically, this webinar will cover:
  • Key considerations for creating a robust PMCF plan and updating the clinical evaluation,
  • Strategies for planning and executing PMCF studies,
  • Best practices for using Electronic Data Capture (EDC) systems in PMCF activities.

Watch for free
Key Considerations for Implementing Post-Market Clinical Follow-Up for Medical Devices
Who should attend?
  • Clinical Affairs Professionals and Management
  • Clinical Operations Professionals and Management
  • Clinical Researchers and Project Managers
  • Regulatory Professionals and Management
  • Medical Device Executives
Register Now  

Hosted by

Laura Court
Moderator:
LAURA COURT

Solutions Engineer,
Greenlight Guru
Gabriele Feldmann
Speaker:
GABRIELE FELDMANN

Clinical Operations Manager,
AMS Advanced Medical Services
Phillipe Thiel
Speaker:
PHILIPPE THIEL

Clinical Affairs Expert,
Metecon
Chris Rush headshot1
Speaker:
CHRIS RUSH

Solutions Engineer,
Greenlight Guru

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About Greenlight Guru

Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle.

Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster and with less risk.

Visit our homepage to learn more.

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About AMS Advanced Medical Services

As an experienced CRO (Contract Research Organization), AMS  offers 360° customer support in Clinical Trials for phase I – IV as well as for NIS (Non Interventional Trials).  Our services include Project Management, Monitoring, Data Entry, Data Management, Biostatistics, Pharmacovigilance/Clinical Safety and Medical Writing as well as Quality Management, including the conduction of Audits and provides support in Regulatory Affairs and Market Authorization. 

Visit their website to learn more.

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About Metecon

At Metecon, we are passionate about guiding medical device and in vitro diagnostic (IVD) manufacturers through the complexities of regulatory compliance. With over two decades of experience, we have established ourselves as a trusted partner in ensuring successful and compliant market access across Europe and beyond.
 
Our mission is to simplify complex regulatory requirements and translate them into clear, actionable strategies. But we don't just stop at strategy - we roll up our sleeves and actively support the full implementation of these plans. Whether it's helping to develop new products, optimize existing ones, or navigate new market landscapes, we're with manufacturers throughout the product lifecycle.
 
When you partner with Metecon, you get a dedicated team committed to your success and the peace of mind that all regulatory aspects are expertly managed.

Visit their website to learn more.

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