Expertise

The requirements in the medical device industry are wide-ranging and can be challenging. With Axxos, you will find a competent partner in almost all areas who will support you with commitment and pleasure.

Read more about our specific expertise here below and learn about the overarching specialist areas:
Quality management services, regulatory affairs, healthcare facilities, EU MDR / CH MepV, FDA services, gap analyses and internal status audits, training courses and update services for standards and legislation.

Post-market surveillance

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

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Computer System Validation (CSV)

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

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Development process, V&V

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

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EU- and CH-REP

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.

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FDA Readiness and inspections

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

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Establishment registration, US-Agent

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

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FDA Submissions

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

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QMS for testing and calibration laboratories according to ISO 17025

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

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Qualification and Validation

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

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Quality management system for Healthcare facilities

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

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Risk Management

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

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Swissmedic inspections

Prevent serious consequences with systematic and goal-oriented preparation.

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MDR Technical Documentation

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

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Clinical evaluation of medical devices

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

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