Digital Therapeutics: Combining Technology for Better Health Outcomes
Digital therapeutics (DTx) are evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder […]
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
Microbiome Based Therapies : Regulations and Market Outlook
Microbiome-based therapies are a promising area in precision medicine, aiming to tailor treatments based on individual microbial compositions. These therapies
Nano-Biotechnology: Tiny Innovations With Big Impact On Biologics
Nano-biotechnology is an interdisciplinary field that combines nanotechnology and biotechnology to manipulate and study biological systems at the nanoscale. The
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,
Artixio Introduces Regulatory Training Services for MedTech Industry
Artixio, a leading provider of regulatory compliance training, today announced the launch of its MedTech Regulatory Training services program for