Description

Pure Global is a medical device regulatory consulting company, certified under the BSI ISO13485:2016 quality management system. Our seasoned team, many of whom are holders of the Regulatory Affairs Certification (RAC), utilizes extensive industry expertise and international scope to help our clients expand globally.

As a premier entity in the regulatory domain for medical devices and in vitro diagnostics, we boast a worldwide consulting team that is well-versed in regulatory requirements and rich in clinical knowledge. Our ISO 13485 certification underscores our dedication to offering superior guidance through the complex global regulatory environment.

Navigating the introduction of new products to the market can be complex, but we're here to support you. Our extensive network includes clinical sites and biobanks that aid in meeting your clinical and regulatory needs. Our comprehensive service offerings include:

• Regulatory Assistance
• Clinical Trial Facilitation
• Local Representation
• Monitoring Post-Market Activities
• Tests for Biocompatibility, Packaging, and Sterilization Validation
• AI & Data Services
  • Market Analysis
  • Recent Regulatory Developments
  • Clinical Research Records
  • Worldwide Distributor Records
  • Management of Certifications

Services Offered by Pure Global to MedTech Companies
Pure Global provides a wide array of specialized services designed for MedTech companies, including assistance with market registration, regulatory compliance, quality assurance, local representation, and clinical support. We deliver strategic aid to help navigate the complexities of regulatory adherence and market entry, ensuring that products adhere to international norms and achieve commercial viability.

How Pure Global Facilitates Global Market Entry for Companies
Pure Global's network of experts and local representatives, stationed in various global offices, expedites the processes of securing and maintaining market access. We assist our clients by providing market assessments, managing product lifecycles, and offering specialized training, which are crucial for penetrating new markets and maintaining compliance internationally.

Overview of the Global Regulatory Intelligence Platform (GRIP)
GRIP is an all-encompassing platform that monitors regulatory trends across more than 100 countries, delivering expert analysis and detailed information on millions of products in 30 regions. It covers product classifications, standards, catalog information, and key specifications, empowering companies to remain informed and compliant with worldwide regulatory demands.

Who Benefits from Pure Global's Services?
Pure Global's offerings are tailored to meet the needs of medical device and in vitro diagnostic manufacturers, ranging from budding startups to established multinational corporations. We offer dynamic regulatory guidance for startups, strategic support for expanding firms, and sophisticated regulatory strategies for multinational corporations, helping them manage regulatory hurdles and optimize their product lineups.

Clientele and Impact of Pure Address Global
Pure Global has effectively served over 300 clients globally, aiding them in overcoming the obstacles associated with market access and regulatory compliance.

Expertise in Market Access Possessed by Pure Global
With a record of obtaining more than 1900 global registration certificates, Pure Global’s team demonstrates deep expertise and a proven track record in achieving market registrations and ensuring that products conform to all requisite regulatory and quality standards for market introduction.