OUR VALUES

Our business is based on ethical Christian values. Inherent in its execution are the principles of openness, genuine interaction, mutual appreciation and stability.

The respect afforded to our customers, partners and colleagues and also to the material goods we handle, coupled with our values, will lead to both long-term personal and long-term entrepreneurial success.

Honesty

Our interaction with one another and our customers is characterized as honest and forthcoming.

We are always committed to the truth and aspire to communicate openly with our business partners.

Authenticity

Authenticity and integrity is very important to us, both in the business context as well as in our private lives.

Mutual Regard

Our interaction with one another will always be courteous and caring.

Quality

In our services we strive for a quality which not only meets the present requirements but which will surpass expectations and provide a long-term trust with our customers.

Professionalism

Our conduct is professional, will always conform to the latest professional requirements and will take into account future changes in market conditions. Our services fulfil the demands expected by our clients and seek to accommodate their accustomed and individual preferences.

Reliability

Our business partners can rely on us and can trust us to keep our word. If adaptations are required in the terms, deadlines or services we agreed at the outset of any agreement, we are proactive in informing our clients to that effect.

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Quality Management Services

In the highly regulated medical device market, maintaining a quality management system according to EN ISO 13485 – for legal manufacturer additional according Annex IX of the MDR (2017/745) - is key to ensure product quality.

It is our aim to establish a lean, dynamic and user friendly quality management system for you as our customer. A system that you are able to maintain without our support in the mid term - we like to see our clients grow and prosper!

FDA Services

Companies selling products in the USA directly or via their distributers or companies that are contract manufacturers for customers selling in the USA must be registered with the FDA and comply with FDA requirements according 21CFR820. Once registered, the FDA can announce an inspection at your site any time. A solid preparation is key to survival.

US-agent and registration support

Together with our partner we offer US-agent services and support your company during establishment registration.

FDA readiness and mock-inspections

We offer FDA GAP-analysis and FDA readiness projects. Furthermore, an experienced Ex-FDA Inspector collaborates with us offering FDA Mock-Inspections and US-Agent Services.

FDA inspection and readiness

During an inspection we take on operative roles such as speaker and translator and we organize the frontroom or backroom. After an inspection, we support you in communicating with the FDA and mastering any non-conformities.

Clinical Evaluation

To demonstrate the safety and effectiveness of your device throughout the product life cycle you need to have an up to date clinical evaluation report in compliance with MEDDEV 2.7/1 Rev. 4 and EU MDR 2017/745 requirements.

We are happy to support you in the planning, compilation or update of your clinial evaluations for any medical devices taking account of your individual priorities.

Computer System Validation

AXXOS can support and assist you with Computer System Validation and optimization of related processes. Important to know is that we fulfil the expectations of the MedTech industry and will not go beyond the necessary demands.

Qualification and Validation

With great experience we develop concepts for qualification and validation complying with regulations and of maximum benefit for the company. We offer reports that are bulletproof in audit situations and at the same time meet customer requirements.

We establish processes together with our customers and either actively execute them or coach the responsible staff by transferring our knowledge.

Auditing

We execute internal audits and supplier audits to verify your compliance with ISO 13485 / 9001 / 9100, MDR Annex IX and FDA’s regulatory requirements. Our auditors are IRCA certified lead auditors.

Training / Lecturing

Axxos organizes trainings on topics listed above, leads parts of training courses at SAQ Qualicon and offers individual trainings tailored to your company's needs. Additionally, Axxos is regularly lecturing at congresses and seminars.

Up-to-date with standards and laws?

Regulatory requirements grow and change over time and dependent on a company’s product range. In order to guarantee compliance at all times, regulatory changes and updates of norms and laws/directives must be monitored and verified. At Axxos you can order your personal update service and we will take care of the yearly monitoring.

Technical Documentation support:

Qualified though many years of practical experience in the medical device industry, we are able to support you in establishing and maintaining the Technical Documentation (TD) according to annexes II+III of MDR (2017/745).

This includes:

• Gap analysis of your actual documentation to the requirements of the MDR
• Ready for submitting review of the TD
• Interrelation between reports such as SSCP, PSUR, CER, PMCF, PMS
  
• Maintaining the TD up to date