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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
March 14, 2023

Alternatives to PMCF Clinical Investigations

Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance in the EU. PMCF Studies are commonly mentioned throughout the EU MDR and guidance documents.

But a PMCF Study does not always have to translate into an interventional or observational Clinical Investigation.

In this webinar, leading MedTech experts from QServe and Greenlight Guru Clinical will share their insights on alternatives to PMCF clinical investigations and suggest ways manufacturers can accommodate clinical data to comply with the PMCF requirements under the EU MDR.

Watch the webinar
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Specifically, this webinar will cover:
  • Alternatives to a full-scale PMCF clinical investigation
  • Key points for when to use an alternative method
  • How to select the best alternative for your device
  • How to remain compliant when using an alternative method
Who Should Attend?
  • Medical device manufacturers with existing products on market in EU or with aspirations to go to market in Europe.
 Register Now  

Hosted by

Bianca Lutters - Rune Sørensen

Presenter: Bianca Lutters

PhD & Head of Clinical Operations & Principal Consultant, Qserve Group
JIB-Head - Rune Sørensen
Presenter: Jón Bergsteinsson

Co-Founder of Greenlight Guru Clinical

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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 homepage to learn more.

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About Greenlignt Guru Clinical

Greenlight Guru Clinical is the leading clinical data collection toolbox, purposefully built for MedTech. Collect and manage clinical data in pre and post-market clinical studies, including registries, cohorts, surveys, human factor testing, design validation, and more.

Greenlight Guru Clinical meets the regulatory requirements of the FDA, EU, and most other countries, and ensures compliance out-of-the-box with GCP and ISO 14155:2020.

Visit our website to learn more.

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