Anteris medical associates come from the life sciences and medical device engineering - and thrive at navigating the interface between both worlds

Combination Products

Combination Products - One pillar of anteris medical's project portfolio is the support of drug/device combination products anteris medical has key competencies in the project management, regulatory affairs and quality consulting for autoinjectors; pens, and needle-safety devices.

Medical Devices and IVD

Medical Devices - anteris medical also has extensive knowledge in class I, class II, and class III medical devices, as well as IVD medical devices, and supports costumers during every phase of the product lifecycle.

Tools

Technical documentation is easily managed by appropriate software tools. Especially in the field of requirements engineering and documentation anteris medical can offer slim but effective tools to make sure your DHF documentation is always up to date.

  • tachysCP: the unique and unrivalled anteris solution for the development of combination products. The tool comes fully packed with a predefined catalog of requirements and risks specific for combination product development.
  • Matrix Requirements Medical: the bedrock of tachysCP and our absolute recommendation for the development of any medical device or IVD. Matrix Requirements Medical is the epitome for instant and intuitive use and flexibility ensuring true assistance at any level of complexity.
  • We are also experienced in the implementation of any other tool available in the market.

 

Project examples

Germany Global player in biosimilars: anteris develops several combination products using autoinjectors, pens, needle-safety devices
Europe Regional player in generics and biosimilars: anteris develops two combination products using needle-safety devices and autoinjectors
Germany SME in medical devices: anteris develops active medical device and supports 510(k) filing
Europe Global player in biosimilars: anteris develops several combination products using autoinjectors, pens, needle-safety devices
USA Stock-listed biotech: anteris develops combination products using needle-safety devices and autoinjectors
USA Global player in materials and medical devices: anteris supports development of a novel component of injection systems
Germany Stock-listed biotech: anteris develops combination product using innovative injection system
USA Global player in generics: anteris develops regulatory strategy for market entry and defense