Titans Medical

Introduction In the rapidly evolving landscape of healthcare, the quality and safety of medical devices are paramount. To ensure that medical devices consistently meet the stringent requirements necessary for patient safety, manufacturers turn to ISO 13485, an internationally recognized standard for quality management systems (QMS) specific to the medical device industry. Compliance with ISO 13485 […]

Introduction Ensuring compliance in the medical device industry is crucial for patient safety, regulatory approval, and market success. However, navigating the complex landscape of regulations can be challenging. Below, we outline the top five medical device compliance mistakes to avoid, helping companies steer clear of common pitfalls. 1. Inadequate Documentation and Record-Keeping Documentation is the

Introduction: Navigating the regulatory landscape for medical device approval can be a daunting task, but the Abridged Pathway offers a streamlined route for manufacturers aiming to enter the Thailand market. This expedited process significantly reduces the approval timeline to less than 150 days by leveraging approvals already obtained from reputable international regulatory bodies. Key International

Introduction: The journey to bring a medical device to market in the United States involves navigating the rigorous approval process of the Food and Drug Administration (FDA). This process ensures that devices are safe and effective for public use. Here is a comprehensive guide on the key steps involved, including premarket notifications (510(k)), premarket approval

Introduction: In the dynamic world of healthcare, medical devices play a crucial role in diagnosing, treating, and managing various health conditions. From simple bandages to sophisticated imaging machines, the spectrum of medical devices is vast. However, ensuring these devices are safe and effective is paramount, which is where medical device regulations come into play. This blog post

Introduction: The United Arab Emirates (UAE) is a rapidly evolving hub for medical innovation and healthcare services. For manufacturers aiming to introduce medical devices into this dynamic market, understanding the regulatory landscape is crucial. In this blog post, we will guide you through the classification requirements for medical devices in the UAE, ensuring you have