Carefully Curated Publications for MedTech clinical teams

Continuously updated publications developed by medical device industry experts to help study sponsors simplify their clinical studies

Ultimate Guide to Device Class Requirements under EU MDR

An in-depth guide on EU MDR medical device classification and requirements

In order to earn a CE marking, medical device companies need to comply with the legislation's numerous safety, technical, and post-market requirements. This can be an extremely challenging process, particularly for companies new to marketing devices in the European Union.

That is why we have created this guide. Along with instructions on how to classify and categorize your devices, you’ll learn exactly what you need to know when it comes to:

  • Preparing technical documentation (what, and when to submit), including PSURs, PMCFs, and SSCPs
  • Conducting clinical evaluations and collecting clinical data
  • Running post-market studies, and much more!

The Medical Device Sample Size Cookbook

A brief guide on the process of sample size calculation for medical device studies

To pass the scrutiny of regulators and Notified Bodies, companies will need to provide statistical and clinical justification of the sample size calculation.

The calculation of sample size is not the most straightforward process and often leaves clinical teams wondering which method to use. Get your copy and learn:

  • The importance of sample size calculation
  • How to calculate sample size
  • Sample Size Calculation Examples

How to tackle PMCF for your Medical Device under the MDR

PMCF is a chance to develop stronger clinical claims while gathering information on usability, design and off-label use

With the right implementation of PMCF safer medical devices will reach healthcare. But that begins with a clear understanding and guidance on PMCF. Get your copy and learn:

  • What are the different activities that can be used to conduct PMCF?
  • PMCF Guide
  • PMCF Success Stories & more

How to Plan a Clinical Data Management Setup for EDC

Eliminate delays, reduce errors, and increase data quality

The key to an efficient data management setup is to design a rigorous data management plan. Request your copy and learn:

  • How to design the data management plan for your study
  • What to consider before setting up a study for EDC
  • How to increase the efficiency in testing and planning

Navigating the EU MDR - Strategies for Success

The EU MDR - Driving a safer healthcare ecosystem

Although new and innovative devices can transform healthcare, there’s a growing need to regulate the MedTech industry - not only to protect the patients but to leverage its full potential. Request your copy and learn:

  • The most notable changes of the MDR
  • What to consider in terms of new clinical requirements
  • What to expect as a manufacturer

Optimising Clinical Evaluation for Medical Devices

Improve the process, not just the tools

This white paper includes three key actions on how the process of clinical evaluation can be optimised by providing the answer to the questions below.

  • Why is it important to digitise data collection in clinical investigations?
  • How can we improve protocol design?
  • How can you achieve higher quality evidence?

How to Design an Electronic Case Report Form (eCRF)

Design better forms, save time and lower costs

With better designed forms, we’ve seen increased compliance rates, better data quality, and better communication between study participants. This has lead to decreased time spent on data management, which results in lowered costs, and eventually shorter time to market. Request your copy and learn:

  • The 7 principles of an optimal eCRF design process.
  • How to speed up your eCRF design process
  • How to acquire more quantifiable data