Biocompatibility evaluation according to ISO 10993-1 is one of the most important validation activities for…
ISO 20416 post market surveillance
Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview…
Introduction Computer System Validation is an extremely important subject for Quality Management System of highly…
FDA Digital Health Devices Regulation – Pre-Cert Program FDA has launched the so-called Software Pre-Cert…
Very recently, ISO published a new version of ISO 14155:2020 – Clinical investigation of medical…
ISO 15223-1:2020 new symbols for medical devices In this paragraph, we will talk about the…
Insights into the ISO 13485 certification process for Quality Management System. ISO 13485 certification is…
ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO…
The regulation of General Wellness Devices In recent years, there was a big increase in…