Trainings

Empowering people is close to our hearts. Building and retaining skills is a key process in medical device technology and we at Axxos are experts in maximizing the learning effect.
Competent employees are the foundation of a successful company.

Our trainers at Axxos have many years of experience in medical device industry and in rhetoric and didactics. All training courses are created with a strong focus on learning atmosphere, learning experience and practical implementation. Various media such as scripts, (as few as possible) PowerPoint slides and flipcharts are used depending on the situation, always to maximize the learning effect.

We develop learning content and are permanent instructors at SAQ Qualicon and Sitem Insel, Bern. For in-house training courses, we combine the theoretical basics with company-specific content to create training units. We enjoy the interaction of face-to-face training and also have a lot of experience in how to teach exciting online trainings.

We offer dedicated training in all our areas of expertise and ensure that specific knowledge and skills are built up and consolidated. This is how quality creates additional organizational value.

Quality Management Services

In the highly regulated medical device market, a quality management system to maintain product quality is generally mandatory. Axxos has many years of experience in setting up, implementing and supporting the certification of quality management systems in accordance with EN ISO 13485 and 21CFR820 (FDA) for manufacturers, distributors and suppliers.

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Regulatory Affairs

Whether you need technical documentation for CE marking in Europe, documentation and submission of a 510k for registration on the American market or all facets of risk management – with Axxos you have a partner who can support you in all areas of regulatory requirements.

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FDA Services

From 510(k) to FDA inspection support, Axxos has many years of hands-on experience in complying with and implementing FDA medical device requirements.

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Healthcare facilities

The requirements for healthcare facilities and institutions are diverse. An efficient quality management system is the key to successful audits or Swissmedic inspections. Axxos supports in implementing the requirements of Swissmedic or the canton in the quality management system in a user-friendly and practical way.

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EU MDR, MedDO

The medical device sector has many challenges for manufacturers or suppliers, in Europe under Regulation (EU) 2017/745 (MDR) in the USA or in Switzerland under the MedDO. Our experts at Axxos will help you to successfully maneuver through the requirements with clever registration strategies or find tailor-made solutions for your situation.

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