The platform amalgamates data from over 30 markets, providing various tools to navigate regulatory requirements, monitor medical device registrations, and analyse clinical trials utilising AI-driven insights.
This article was originally published on IT Brief Asia.
Pure Global has introduced the Pure Global Resource Centre, a comprehensive platform to accelerate market access for MedTech companies and streamline their go-to-market strategies. The platform amalgamates data from over 30 markets, providing various tools to navigate regulatory requirements, monitor medical device registrations, and analyse clinical trials utilising AI-driven insights.
With the complexity of managing diverse global markets, the Pure Global Resource Center offers extensive data on regulatory requirements, clinical trials, and medical device registrations. Key features of the platform include a comprehensive database that provides access to over 4 million medical device registrations and detailed clinical trial data. This database offers insights into study sites, sponsors, diseases, and study stages.
The platform includes tools for tracking the latest regulatory changes and managing global product registrations to assist with regulatory compliance. It also features a translation platform that supports over 20 languages, facilitating efficient global communication. The platform leverages AI to analyse regulatory updates, enhancing compliance and decision-making processes.
Phyllis Meng, CEO and Co-founder of Pure Global, said, "The Pure Global Resource Center combines an unparalleled level of depth and breadth of data with market insights tailored specifically for MedTech companies. By combining the power of our platform with the expertise of our local market specialists, Pure Global can guide clients in identifying the most efficient and effective routes for bringing their products to the market."
The platform's customisable solutions enable organisations to modify specific features or opt for full on-premises deployments, catering to diverse needs. The solutions range from internal certification management to global product tracking.
Additionally, the Resource Centre utilises local market specialists' insights to guide clients' strategic market entry, ensuring informed decision-making tailored to specific regional requirements. The platform's AI-powered analysis further aids in understanding and navigating complex regulatory frameworks.
Looking ahead, Pure Global plans to showcase the Pure Global Resource Centre at the RAPS Convergence 2024 event in Long Beach, allowing industry professionals to explore the platform's capabilities firsthand. As a company specialising in next-generation solutions for MedTech firms looking to expand globally, Pure Global is committed to continuously enhancing the Resource Centre based on client feedback and technological advancements.
By deepening the integration of artificial intelligence and expanding platform functionalities, Pure Global aims to address the challenges of global market access better, helping clients make informed decisions, refine market entry strategies, and navigate the complexities of international standards with the support of expert guidance from local market specialists.
Browse our news hub featuring company announcements, regulatory updates, and industry insights to keep you informed and ahead of the curve.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.
.png)
As 2024 comes to a close, Pure Global proudly reflects on a transformative year marked by substantial growth, cutting-edge innovation, and impactful collaborations.
IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.
(3).png)
On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.