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

Post-market surveillance (PMS) activities have received a stronger focus as a result of Regulation (EU) 2017/745 (MDR). The requirements for the post-market surveillance plan in accordance with MDR Annex III have increased. Furthermore, there are more stringent requirements for post-market clinical follow-up (PMCF). Axxos provides support in understanding the requirements and implementing them specifically for each medical device.

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Computer System Validation (CSV)

In times of digital transformation and the rapidly changing work environment, computerized, digitized and automated processes are among the central key factors of a modern company.

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Development process, V&V

From the product idea for a new medical device through design verification and validation to market release: an efficient development process facilitates the realization of new products and simplifies the path to the necessary documentation for product approval/clearance in Europe or the USA.

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EU- and CH-REP

Since the expiry of the MRA (mutual recognition agreements) in spring 2021, the distribution of Swiss products in the EU requires an EU authorized representative and the distribution of foreign medical devices in Switzerland requires a CH authorized representative.
In both cases, Axxos offers this service in cooperation with partners.

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FDA Readiness and inspections

With its registration, a company confirms that it fulfills the requirements of the FDA, such as 21CFR820 for example. It is therefore possible (at any time) for the FDA to announce an inspection. If you are not well prepared, you risk a warning letter.

An FDA GAP analysis identifies potential gaps. In the subsequent FDA Readiness Project, these gaps are closed and the entire organization is brought up to speed with the FDA requirements. With an FDA mock inspection by an experienced former-FDA inspector, the atmosphere related to an FDA visit can be simulated and trained.

An FDA inspection is a huge challenge for any company and usually a great unknown, as there may be a lack of experience with the American authority. The long-term and short-term preparation for an inspection or the use of FDA experienced senior consultants from Axxos as speakers, translators or back-room coordinators simplifies the process and increases the probability of a successful FDA inspection.

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Establishment registration, US-Agent

Are you planning to supply medical devices directly or via your customers to the USA or were you asked by your customers to register as a company with the FDA? Axxos is your competent partner to evaluate the registration obligation and supports you in the registration process with appropriate know-how or training.

We also have a suitable solution for the required appointment of a US agent.

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FDA Submissions

The marketing of medical devices in the USA requires an establishment registration, product listing and in many cases a clearance or an approval by the FDA. It is worth examining the options at an early timepoint and developing a smart registration strategy. Axxos puts itself in the position of the organization and develops suitable clearance/approval strategies, prepares and coordinates the submission file and provides support during the submission process from pre-sub to 510(k). The goal is always a successful entry into the US market.
Of course, Axxos also offers in-house training in all areas of knowledge.

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QMS for testing and calibration laboratories according to ISO 17025

Accredited testing and calibration laboratories require a certified quality management system in accordance with ISO 17025.It also makes sense for internal testing laboratories to set up their processes in accordance with ISO 17025. Axxos supports the implementation of a quality management system and the auditing of external testing laboratories.

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Qualification and Validation

Equipment qualification and process validation are crucial requirements in the manufacture of medical devices. The experts at Axxos evaluate the most efficient and best validation strategy and implement it during the validation phase, either operatively themselves or through coaching of the internal validation personnel.

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Quality management system for 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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Risk Management

Risk management is one of the foundations for bringing a safe and high-quality product to market. Axxos has a large expertise with the diverse requirements for risk management and provides support in implementing these systematically depending on the product risk class.

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Swissmedic inspections

Both manufacturers and users of medical devices can be inspected by the authorities (Swissmedic, cantons) at any time. We therefore recommend that all medical device manufacturers, healthcare facilities, hospitals, etc. prepare systematically and specifically for an inspection in order to prevent serious consequences.

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MDR Technical Documentation

The MDR has a major impact on the technical documentation for medical devices. Depending on the risk class, it can become very extensive. Our experts at Axxos will assist you in preparing the corresponding files in accordance with Annex II of (EU) 2017/745.

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Clinical evaluation of medical devices

The clinical evaluation examines the safety and performance of a medical device. If you are unsure whether the level of clinical evidence for your medical device is sufficient, when drawing up a clinical evaluation plan, conducting a systematic literature search or preparing a clinical evaluation report – the experts at Axxos can help you in a quick and reliable way!

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