Careers Support Contact Sales
Products

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

Learn More

Featured Capabilities:

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

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

View Product Tour

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

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

Get a personalized demo of Greenlight Guru Clinical today.

See the Demo

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

Learn More
Solutions
Why Us
Customers
Partners
Company
Resources
ROI Report Cover

Calculate Your ROI
See the Demo
See the Demo
See the Demo

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 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

qserve_logo

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.

Featured In