anteris medical

Medical devices

anteris medical supports the pharmaceutical, biotech and medical device industries globally by managing the development of drug/device combination products (DDC), medical device products and in-vitro diagnostics (Dx). Their broad competencies cover compliance, regulatory affairs combined with innovative, resource-efficient solutions for compliant development and technical documentation (including risk management, requirements engineering, human factors engineering and dossier preparation) as well as post-marketing surveillance expertise. The medical team consists of life sciences and engineering majors with dozens of years of experience in CE marking, 510(k) submissions, BLA, 505(b)(2), 505(j), 351(k), and quality systems regulations in all major markets.