The focus on post-market surveillance has increased. Axxos provides concrete support in this area

Computer-assisted, digitized, and automated processes are among the key success factors of a company.

An efficient development process facilitates the realization of new products and simplifies the path to product approval or clearance in Europe or the USA

After the termination of the Mutual Recognition Agreements (MRA), Axxos provides the required service of EU and CH Authorized Representatives for the distribution of medical devices in these countries.

We ensure that you won’t face any unpleasant surprises during an FDA inspection.

To deliver products to the USA, both manufacturers and suppliers require FDA registration. Axxos offers the appropriate expertise to support you in this matter.

Axxos develops suitable regulatory strategies, prepares and coordinates submission files, and provides support throughout the submission process.

Axxos supports you in the implementation of a quality management system according to ISO 17025 and the auditing of external testing laboratories.

Equipment qualification and process validation are critical requirements in medical device manufacturing – we support you in meeting them.

Axxos supports you in implementing the requirements of Swissmedic or the canton in a user-friendly and practical manner.

A systematic and relevant risk management approach ensures your product is marketed safely and with high quality

Prevent serious consequences with systematic and goal-oriented preparation.

The experts at Axxos are happy to assist you in preparing the technical documentation in accordance with Annex II of (EU) 2017/745

The experts at Axxos know whether the extent of clinical evidence is sufficient – quickly and reliably!