Switzerland’s Medical Device Regulation and the EU Regulations
The medical device industry is thriving globally. Not only in European Union countries, but the influence is also seen in neighboring countries…
20 Nov 2025
12 EU MDR Guidance Documents You Need
EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With…
20 Nov 2025
Clinical Evaluation Assessment Report Rubric: What Does It Mean For Your MDR Submissions?
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR)…
20 Nov 2025
Managing Clinical Evaluation Report (CER) and Literature Review Teams
Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer’s job is not only to…
20 Nov 2025
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
For medical devices specifically, the 2022 Blue Guide doesn't add much that MDR and IVDR don't already cover in more detail. It…
20 Nov 2025
EU MDR: Combination Products – An Overview
We all know and love (ahem) the EU MDR (2017/745). And although it is defined as the EU Medical Device Regulation, it…
20 Nov 2025
Fundamentals of a Literature Review: A Beginner’s Guide
The medical device industry is fueled by innovation. Research and development are the blood that keeps it going. Each day, we advance…
20 Nov 2025
Understanding Global Regulatory Authorities in the Medical Device Industry
You know what is common in all countries? No matter the geographical position, the culture, the people or religion? No one wants…
20 Nov 2025