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Innovative Drug Delivery Systems
While traditional oral pills remain a cornerstone of drug delivery due to their simplicity and familiarity, innovative drug delivery...
Jul 26, 20245 min read
Regulatory Contract Staffing in Mexico for a Leading Medical Device Manufacturer
Artixio, a trusted player in the regulatory and commercial arena, provided contract staffing solutions to a global leading medical device...
Mar 7, 20242 min read
Case Study: Successful Registration of Software as Medical Device (SaMD)assisting Surgical procedure
Client: The client, a pioneering European company specializing in advanced medical technologies, sought regulatory approval for its...
Jan 9, 20242 min read
Demystifying the Role of Indian Authorized Agents in Medical Device Registration
In the intricate landscape of medical device regulations in India, the role of the Indian Authorized Agent (IAA) stands as a pivotal link...
Dec 2, 20233 min read
Medical Device Regulations and Registration in Canada (Health Canada)
In Canada, the medical devices are regulated by Health Canada under Health Products and Food Branch, Therapeutic Products Directorate,...
Nov 27, 20234 min read
CDSCO Medical Devices Regulations In India
Medical devices are emerging globally and India serves as the 4th largest market in Asia for medical devices. India aims to accelerate...
Nov 25, 20238 min read
Understanding the Significance 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 a...
Nov 23, 20233 min read
ISO 13485:2016 Certification for Medical Devices Quality Management System
In the realm of medical devices, ensuring safety, reliability, and compliance is paramount. The International Organization for...
Nov 17, 20234 min read
QMS Certification through Medical Device Single Audit Program (MDSAP)
In an era of advancing healthcare technology and globalized markets, ensuring the safety, quality, and compliance of medical devices is...
Nov 16, 20234 min read
COFEPRIS Technovigilance of medical devices in Mexico
In the dynamic landscape of healthcare, ensuring the safety and efficacy of medical devices is paramount. As technology continues to...
Nov 13, 20234 min read
Taiwan Food and Drug Administration (TFDA) Medical Device Regulation in Taiwan
Taiwan is a growing market for medical devices, but gaining entry requires strict adherence to Taiwan medical device regulations set...
Nov 8, 20234 min read
Medical Device Registration Pathways in Mexico : Standard and Expedited Review Routes
Mexico is a growing market for medical devices, and medical device manufacturers are increasingly looking to register their products in...
Nov 2, 20234 min read
Regulation of Medical Devices with Philippines Food and Drug Administration (PFDA), Philippines
In the Philippines, the medical device industry relies heavily on imports for its products. Â Whether these products are made...
Oct 27, 20234 min read
Health Sciences Authority (HSA) Medical Device Dealers Licenses in Singapore
The Health Sciences Authority (HSA) functions as the regulatory authority responsible for overseeing medical devices within the country,...
Oct 25, 20235 min read
The Q-Submission Meetings for Medical Devices with US FDA
The US Food and Drug Administration (US FDA) Q-Submission Program serves as a vital channel for medical device manufacturers to engage...
Oct 23, 20236 min read
Local Representative for MDR in Mexico:Mexican Registration Holder (MRH) for COFEPRIS Communications
In recent years, Mexico has emerged as a highly attractive destination for businesses looking to expand their operations, particularly in...
Oct 21, 20233 min read
Medical Device Regulations in India : A Closer Look at CDSCO Application Forms
The Central Drugs Standard Control Organization (CDSCO) in India plays a pivotal role in regulating the manufacture, sale, and...
Oct 19, 20234 min read
Medical Device Regulations in Thailand (Thai FDA) : Device Registration Pathways
Thailand is renowned for its stunning landscapes, rich culture, and world-class healthcare. The country has been steadily growing as a...
Oct 18, 20236 min read
Health Sciences Authority Medical Device Regulations : Advertisements and promotions in Singapore
The world of advertising is dynamic and ever-evolving, especially when it comes to the promotion of medical devices. Ensuring that these...
Oct 17, 20236 min read
Medical Device Registration in USA : 510(k) Registration with US FDA
In the realm of medical devices, regulatory compliance is paramount to ensure patient safety and effective product performance. The...
Oct 11, 20234 min read
Insights
Global, Concurrent, Experience Based
Deep dive and engage in insightful discourse driven by concurrent global regulatory scenarios, industry trends and Artixio’s real-time experience across the product value chain. Whitepapers, research articles, landscape reports and case studies to help you stay ahead of the curve.
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