Continuously updated publications developed by medical device industry experts to help study sponsors simplify their clinical studies
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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:
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:
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:
The key to an efficient data management setup is to design a rigorous data management plan. Request your copy and learn:
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:
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.
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: