Description
Pure Global is a medical device regulatory affairs consulting company that is certified with the BSI ISO13485:2016 quality management system. Our team of experts, many of whom hold Regulatory Affairs Certification (RAC), leverages industry experience and cross-border capabilities to assist our partners in achieving global growth.
As a global leader in regulatory affairs for medical devices and invitro diagnostics, we take pride in our consulting team spread across the world, equipped with regulatory certifications and extensive clinical experience. We are ISO 13485 certified to demonstrate our commitment to providing you with expert guidance through a rigorous global regulatory landscape.
Bringing new products to the market can be challenging and we are here to help. We have a robust network of clinical sites and biobanks to support your clinical and regulatory requirements. We offer a wide range 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).
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