The Pure Global Resource Center consolidates data from over 30 global markets with local expertise, simplifying global standards to identify the most effective market entry routes.
This article was originally published on Healthcare Packaging.
Pure Global announces the launch of the Pure Global Resource Center, a one-stop platform designed to accelerate MedTech market access and streamline go-to-market strategies. Addressing the growing need for a comprehensive understanding of market opportunities and regulatory requirements, the Resource Center provides access to the latest regulatory pathways for major markets.
The Pure Global Resource Center brings together information on over 30 global markets into a single, accessible hub. This allows manufacturers to compare market access requirements easily and prioritize their strategies for market entry. The platform features a vast database of over 4 million medical device registrations and an extensive clinical trials database, offering insights into study sites, sponsors, diseases, and study stages.
“The Pure Global Resource Center combines an unparalleled level of depth and breadth of data with market insights tailored specifically for MedTech companies,” said Phyllis Meng, CEO & co-founder at Pure Global. “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.”
For regulatory compliance, the platform includes tools for tracking the latest regulatory changes and managing global product registrations from one location. It includes a translation platform that enables document translation into 20+ languages for efficient global communication. Additionally, AI-powered analysis of regulatory updates enhances compliance and decision-making.
The platform is highly adaptable, offering customizations to meet diverse organizational needs, from internal certification management to global product tracking. Customization options range from specific feature adjustments to full on-premises deployments.
Looking ahead, Pure Global plans to continually enhance the Resource Center based on client feedback and technological advancements, with future updates focusing on deeper integration of artificial intelligence to further address global market access challenges.
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.