Emergo Group is based in Austin, Texas and provides quality and regulatory compliance consulting to medical device and IVD companies. The company assists with US FDA 510(k) clearance, CE Marking for Europe, plus medical device approval in Canada, Japan, China, Mexico, Brazil, Korea, India, Russia and Australia. The company also assists with medical distributor search. Offices in North America, Europe, Asia and Australia. Specialties Medical device regulatory consulting, FDA 510(k) approval, CE Marking, ISO 13485, FDA GMP, medical distributor search

Our website offers the only complete source for current regulatory and support documents - all available for quick referencing or downloading. In addition, we offer the following features to aid our customers in using all data housed on our site: * The reformatting of hard-to-read regulations and compliance manuals; * The cross-referencing and hyper-linking of regulatory data to other relative compliance documents; * The inclusion of regulatory release dates plus the additions of page numbers, tag number listings, and bookmarks to regulations and compliance documents; and * Customizable policies, procedures, job descriptions, training programs and risk management tools, among others, to aid in meeting compliance issues.

PaxMed is a regulatory and clinical trials consulting firm specializing in services to manufacturers of implantable medical devices. These services include regulatory strategy; submissions to FDA and international regulatory bodies; design and management of clinical trials (strategy, protocol development, CRFs, monitoring, data management, biostatistics and reporting); and development and implementation of quality systems. Biomaterials specialties include ceramics, metals, bioabsorbable polymers, and tissue engineering. Device specialties include spinal implants, bone void fillers, orthopedic implants, and dental implants.

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Envirosure Solutions, LLC is a comprehensive environmental, health, and safety (EHS) compliance service company based in Tempe, Arizona. We serve a diverse industry clientele across the entire spectrum of SIC and NAICS codes including both Fortune 500 and Fortune 50 firms. Our client base of over 400 accounts spans a wide range of manufacturing and service industries, and is served by an in-house team of EHS professionals experienced in the development of custom cost effective compliance programs. State-of-the-art proprietary technology allows us to efficiently accommodate all local, county, state, and federal EPA, OSHA, DOT, and DHA compliance requirements impacting companies coast to coast. We handle your EHS compliance requirements in turn-key fashion for a fraction of the cost.