NCBiotech Company Directory

A comprehensive listing of North Carolina's life science industry

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Showing 1 - 10 of 10 results found.

Activity Company Description Location
Company FDA Consulting LLC Activity: Support and Related Support and Related Company Description FDA Consulting offers quality management systems, regulatory strategies and submissions for medical devices and in vitro diagnostics. Location Raleigh
Company Focus 42 LLC Activity: Support and Related Support and Related Company Description Focus 42 provides consulting expertise for medical device software development, in vitro diagnostics (IVD), Mobile Medical Applications (MMA) and Software as a Medical Device (SaMD) for FDA/EU/cFDA compliance. Location Cary
Company Health AnalytiKa LLC Activity: Support and Related Support and Related Company Description Health AnalytiKa offers healthcare consulting services, including regulatory and quality analysis, medical device registration and post-market surveillance. Location Iron Station
Company Kapstone Medical LLC Activity: Support and Related Support and Related Company Description Kapstone is a single-source service provider to medical device companies lacking the appropriate human capital to commercialize new products. Kapstone also supports inventors who need assistance assessing, designing and monetizing their inventions. Location Charlotte
Company knoell USA LLC Activity: Support and Related Support and Related Company Description knoell is a global consulting company that serves the crop protection, industrial chemicals, devices and vet med markets, providing quality assurance, dossier and technical writing, study monitoring, toxicology, registration support and risk assessments. Location Research Triangle Park
Company Nu Device Consulting LLC Activity: Support and Related Support and Related Company Description Nu Device Consulting provides regulatory affairs services and 510(k) submission assistance to medical device companies. Location Cary
Company ProMedoss Inc. Activity: Support and Related Support and Related Company Description ProMedoss supports medical device startups and entrepreneurs in bringing medical devices to market. Services include regulatory strategies, submissions, due diligence, and compliance, clinical trials, quality management systems, and risk management. Location Charlotte
Company The Jans Group LLC Activity: Support and Related Support and Related Company Description The Jans Group provides regulatory affairs and quality assurance consulting to the medical device industry in the areas of product development, regulatory strategy/planning, regulatory submissions (domestic and global), labeling, technical writing, and training. Location Hillsborough
Company TÜV Rheinland of North America Activity: Support and Related Support and Related Company Description TUV Rheinland provides certification services to EN ISO 13485, EU Directives and ISO 13485:2003 under CMDCAS. TUV Rheinland is also accredited by OSHA as an NRTL and offers product safety testing for electrical and medical products. Location Youngsville
Company William Daunch & Associates LLC Activity: Support and Related Support and Related Company Description William Daunch & Associates provides medical device & combination product research & development consulting, helping small, midsize & large biotech companies accelerate the design, development & commercialization of next generation medical technology. Location Cary