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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
JANUARY 16, 2020

What You Should Know When Designing a PMCF Plan for Your Medical Device

According to the KPMG/RAPS survey results published in September 2019, 43% of Medical Device respondents had not started updating their Post-Market Surveillance (PMS) procedures, and 13% didn't even have a PMS strategy in place.

A PMCF plan plays a big role in the new requirements for PMS introduced by the MDR. But the lack of guidance from the European Commission leaves many uneasy and unsure of how to implement a strong PMCF plan to comply with the regulations.

The MDR is very clear on what a PMCF plan should include, but the choice of strategy can greatly vary from one device to another.

If you are looking for guidance on your choice of strategy for your medical device PMCF plan, this webinar is for you.

Watch the webinar
Wiebe Postma Senior Consultant & CRO Lead Qserve-2
Specifically, this webinar will cover:
  • How your PMCF strategy can impact the rest of your portfolio
  • How ethics interplay with your PMCF plan
  • How to justify PMCF data results
  • How you demonstrate sufficient data quality
  • Why you should not rely too much on key opinion leaders (KOL)
Who Should Attend?
  • Clinical Research Professionals and Management
  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Clinical Affairs Professionals and Management
 Register Now  

Hosted by

wiebe postma
Presenter: Wiebe Postma

Senior Consultant & CRO Lead,
Qserve
Jón Bergsteinsson (2)
Presenter: Jón Bergsteinsson

Director of Sales EMEA, co-founder SMART-TRIAL

ST-full color-big - Rune Sørensen

About Smart Trial

The only Electronic Data Capture (EDC) platform designed for Medical Devices & Diagnostics. SMART-TRIAL offers the ideal Electronic Data Capture for clinical investigations, performance studies, and PMCF/PMPF activities - including registries and surveys. SMART-TRIAL is built to empower clinical teams to be their best, and in full control of their data, without compromising on features, design, or compliance.

Visit our website to learn more.

Since June 2022, SMART-TRIAL is a Greenlight Guru product.

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About Qserve

Qserve is your global partner for Medtech Regulatory, Clinical & Quality Compliance and your CRO for Medical Device Clinical Trials.

Our strong international team, located in Europe, China and the United States, combines their broad range of knowledge and expertise in medical devices, to assist manufacturers in gaining market access around the world.

Qserve’s in-house consultants advise in numerous areas, including Regulatory Affairs, Clinical Affairs, CRO, Strategic Planning, Due Diligence & GAP analysis, CE-Marking, Pre-IDE, PMA, 510(k) Submissions, US Agent Representation, CFDA Registration, Trainings & Quality Management Systems implementation.

Visit their website to learn more.

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