Pure Global

Pure Global is a medical device regulatory consulting firm, certified under the BSI ISO13485:2016 quality management system. Our team, many of whom are holders of the Regulatory Affairs Certification (RAC), brings a wealth of industry knowledge and international expertise to support our clients' worldwide expansion.

As a leading authority in regulatory matters for medical devices and in vitro diagnostics, we pride ourselves on our globally dispersed consulting team, who are equipped with regulatory qualifications and deep clinical knowledge. Our ISO 13485 certification underscores our dedication to delivering high-quality guidance through the complex global regulatory environment.

The journey of bringing new products to market is fraught with challenges, but we are here to assist. We maintain an extensive network of clinical sites and biobanks to meet your clinical and regulatory needs. We provide a comprehensive array of services, including: Regulatory Support; Clinical Trial Support; In-Country Representation; Post Market Surveillance; Biocompatibility Testing; Packaging Testing & Sterilization validation; AI & Data Tools; Market Intelligence; Latest Regulatory Updates; Clinical Research Database; Global Distributor Database; Certification Management.