Dirk founded anteris medical together with Michael in 2014. He is a seasoned team leader of pharmaceutical and medical device development teams gone Entrepreneur.
Dirk has more than 15 years of experience in small and mid-size biotech…
Effective project management throughout the entire product lifecycle: keeping projects in time, on budget, and in compliance with ISO 13485 and 21 CFR 820
Comes with a pre-compiled catalog of requirements and risks specific for combination product development.
Without any training or setup needed, you will be able to quickly ensure full traceability and create reports for your technical file and design history file.
Covers all documentation necessary to fulfil compliance to standards combined with the flexibility to be adapted to your specific needs.
Thierry is the General Manager of anteris helvetia. He has more than 12 years’ experience in injection devices and combination products for various application such as diabetes, Parkinson disease or hormone therapies.
He has a focus…
Barbara has more than 13 years of global pharma labeling experience.
She has a strong focus on biosimilars and combination products, profound regulatory labeling experience in development and maintenance of complex generics,…
Astrid is a Human Factors Engineering (HFE) expert with 20 years’ experience in start-up, international mid-sized medtech as well as global pharma companies. She has the understanding of the full development process involving HFE in…
With anteris helvetia we focus our efforts on supporting clients from Switzerland and from outside of EU, who either lack resources familiar with medical device development or wish to complement their existing resources.