We support our customers in their medical device challenges during development, through registration and beyond
Success results from connection - connection of ideas, connection of expertise and connection of experience. Anteris medical has been founded in 2014 and supports the pharmaceutical, biotech and medical device industries globally by managing the development of combination products, medical device products or in vitro diagnostics. Our broad competencies cover compliance, regulatory affairs combined with innovative, resource-efficient solutions for compliant development and technical documentation as well as marketing and sales expertise. We are life sciences and engineering majors with dozens of years of experience in CE marking, 510(k) submissions, and quality systems regulations in all major markets. Let's connect!
Establishment of EU and US compliant development processes and documentation
Effective project management throughout the entire product lifecycle: keeping projects in time, on budget, and in compliance with ISO 13485 and 21 CFR 820
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