Importance of Design History File (DHF) in Medical Device Development
The Design History File (DHF) is a crucial component in the development and manufacturing of medical devices. It serves as […]
MedTech
Medical Devices Registration Regulations In Singapore (HSA)
Singapore has become a key hub for innovative medical technologies, attracting manufacturers and innovators from around the world. However, ensuring
Early Access Program & Approval Process For Unregistered Medicinal Products In Cambodia
The approval process for unregistered medicinal products under Early Access Program (EAP) in Cambodia is as follows: The applicant must
QMS Certification through Medical Device Single Audit Program
In an era of advancing healthcare technology and globalized markets, ensuring the safety, quality, and compliance of medical devices is
ISO 13485:2016 Certification For Medical Devices Quality Management System
In the medical device industry, prioritizing safety, reliability, and compliance is important. The International Organization for Standardization (ISO) established ISO 13485,
Mexico (COFEPRIS) Regulations For Medical Device Registration
The healthcare sector, being a dynamic and rapidly developing industry, relies heavily on medical devices to support diagnosis, treatment, and
Artixio Recognizes Femicura Healthtech as GEMi Grant Winner for Innovative Medtech Solutions
Artixio proudly announces Femicura Healthtech as the recipient of the prestigious GEMi (Grant for Early-Stage Medtech Innovations). The GEMi grant,
Reprocessing Single-Use Devices in accordance with EU Medical Device Regulations (EU MDR 2017/745)
Single-Use Devices (SUDs) are indispensable in the healthcare sector, providing essential tools for medical procedures. While SUDs are originally designed
Precision Medicine – Key Players and Pipeline
Precision medicine, with its promise of tailoring treatments to individual patient characteristics, is revolutionizing the healthcare industry. By focusing on