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 SMART-TRIAL by Greenlight Guru 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

GG-ST-Qserve-Webinar grpahic 3-14-23-3
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 SMART-TRIAL by Greenlight Guru


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.

smart-trial by greenlight guru logo

About SMART-TRIAL by Greenlignt Guru

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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