Pure Global | Medical Device Regulatory Consulting - Health & Wellness in jersey-city-130, new-jersey

Pure Global is a medical device regulatory consulting company, certified under the BSI ISO13485:2016 quality management system. With a team comprising Regulatory Affairs Certification (RAC) holders with deep industry knowledge, we support clients in navigating the complexities of global expansion in the medical device sector. Our expertise extends to medical devices and invitro diagnostics, bolstered by a consulting team globally recognized for their regulatory and clinical experience.

Our services are comprehensive, addressing various facets of market introduction and compliance. We offer regulatory support, clinical trial assistance, in-country representation, post-market surveillance, and biocompatibility, packaging, and sterilization testing. To streamline our clients' processes, we utilize advanced AI and data tools that provide up-to-date market intelligence, regulatory updates, and access to a clinical research database and global distributor network.

Our global representation and registration services encompass key international markets, including the United States (FDA), United Kingdom (MHRA), European Union (CE Mark), Canada (CMDR), China (NMPA), Brazil (ANVISA), Japan (PMDA), and more, facilitating medical device registration and compliance across a broad geographical spectrum. This extensive service offering ensures that clients can efficiently obtain necessary certifications and maintain compliance with diverse regulatory requirements globally.

Headquartered in Jersey City, New Jersey, Pure Global is strategically positioned to assist companies from around the world in meeting the stringent regulatory demands of the medical device industry, ensuring that new and existing products adhere to the highest standards of safety and efficacy. As your partner, we are committed to helping you achieve successful market entries and sustainable growth in the competitive global healthcare market.