EUDAMED Registration: ACT, UDI Modules and Frequently Asked Questions
EUDAMED is the European Union's online database for Medical Devices. It serves as a centralized system where: Manufacturers register their [...]
11 05 2026
11 05 2026
09 02 2026
09 02 2026
Cybersecurity as a regulatory requirement of MDR and IVDR: a guide to EN IEC 81001-5-1:2022
Translated with A.I. For Medical Devices and in vitro diagnostic Medical Devices, cybersecurity is essential to satisfy the General Safety [...]
02 12 2025
02 12 2025
The New FDA QMSR Aligned with ISO 13485:2016: What Changes?
The new Quality Management System Regulation (QMSR) comes into effect on February 2, 2026, following the publication of the Final Rule [...]
06 08 2025
06 08 2025
Guide to Medical Device Printouts: Labels, IFUs and MDR Requirements
According to MDR (EU) Regulation 2017/745, IVDR (EU) 2017/746 and ISO 20417, printed matter comprises all information provided by the manufacturer [...]
10 06 2025
10 06 2025
Post-Market Surveillance of Medical Devices in Great Britain: What’s Changing?
Post-market surveillance (PMS) of Medical Devices in Great Britain plays a key role in ensuring user safety and compliance. With the [...]
23 04 2025
23 04 2025
IVDR Deadlines: All Key Dates for Legacy and Non-Legacy IVDs
The in vitro diagnostic medical device (IVD) industry is going through a challenging transition phase, marked by the IVDR Regulation [...]
18 12 2024
18 12 2024
PMS and PSUR Reports: Key Documents in Post-Market Surveillance
Periodic Safety Update Reports (PMS Reports) and Periodic Safety Update Reports (PSURs) play a central role in the management of Post-Market [...]
19 11 2024
19 11 2024
Trend Analysis in Post-Market Surveillance (PMS)
The European Union's MDR (EU) 2017/745 requires medical device manufacturers to adopt a systematic Post-Market Surveillance (PMS) process to ensure the [...]
15 10 2024
15 10 2024
Medical Devices Change Management in the European Union and MDSAP Countries
Change management in Medical Devices is essential to ensure European and international compliance. After the product is first placed on the [...]
17 09 2024
17 09 2024
Machine Learning-Enabled Medical Devices: a Guide to Transparency
Machine Learning-Enabled Medical Devices (MLMD) represent a revolution in healthcare. These Medical Devices, based on artificial intelligence and machine learning, assist [...]
