The USA is the world’s largest market for medical devices. Manufacturers and suppliers in the role of contract manufacturer must be registered with the FDA in order to market products to the USA.

In Europe, economic operators, including manufacturers, must register in central databases in order to distribute products. Suppliers who are involved in the manufacture of the products however, are exempt from this registration requirement.
In the USA, things are different. There, all companies involved in the manufacture and distribution of finished medical devices must register and renew this registration annually. When registering, information must also be provided on the medical devices produced for the US market and the function of the company.

Registration can have far-reaching and business-critical consequences for the company.

At Axxos, we offer the relevant knowledge, a wide range of practical experience and provide guidance through the registration process.

US-Agent
In order to legally market medical devices in the US, foreign Manufacturers require a local representative, the so-called US agent.
In cooperation with Lance D. Johnson, a long-time former FDA inspector, Axxos offers the US-agent service.

FDA Readiness
With its official 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.

The FDA-specific requirements for a quality management system from 21CFR820 are comparable to the requirements of ISO13485. Nevertheless, a company certified according to ISO13485 does not automatically fulfill all FDA requirements. If critical deviations are found during an FDA inspection, a warning letter may be issued and the distribution of medical devices in the USA may be restricted. Every company listed with the FDA should make specific preparations to achieve FDA readiness. With the FDA readiness the company is ready to specifically prepare for an upcoming inspection within the FDA’s notification period and passthe inspection.

A company that is FDA ready lives compliant and consistent processes with the resulting records. The entire organization is aware of the FDA requirements and knows the inspection process.

Axxos has experience from over 20 FDA inspections and offers the following services on the path to FDA readiness:

• Conducting FDA Readiness GAP analyses to identify gaps in the system and organization
• Addressing the identified gaps with the responsible persons of the organization
• Conducting FDA mock inspections with an experienced ex-FDA inspector
• in house trainings

The aim of Axxos is to build up as much knowledge as possible in the company in order to contribute to the sustainable further development of the company.
During FDA inspections, it was proven to be an advantage that Axxos experts act as translators and represent the company to the inspector.

FDA Inspections
An FDA inspection is a huge challenge for any company and usually a great unknown, as there is a lack of experience with the US 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 offers simplification and increases the probability of a successful FDA inspection.

An FDA inspection cannot be compared to an ISO 13485 audit by a notified body. The inspector is a government official, whose goal is to protect the American public and verify compliance with the relevant laws. Inspections are usually conducted without an agenda and are based on QSIT (the quality system inspection technique). The FDA notifies European companies about 6-8 weeks before an inspection. This time should be used as well as possible to prepare for the inspection.

The experts at Axxos have already successfully accompanied more than 20 FDA inspections without a warning letter. We support:

• in the immediate preparation after the announcement of the FDA inspection
• during the inspection as translator / speaker / host in the front-room /as coordinator in the back-room .
• After the inspection, during communication with the FDA and processing of deviations (483).

The regulatory system for medical devices in the USA differs significantly from the one in Europe. Product clearance or approval is granted by the FDA as the central authority. Our experts at Axxos provide support in the following areas:

• Definition of the best clearance or approval strategy for medical devices (de novo, 510(k), etc.)
• Interaction with the FDA (pre-submission meetings, additional information requests, etc.)
• GAP analyses of existing documentation
• Preparation of 510(k) documentation and support during the submission process
• Further steps required after approval (establishment registration and listing, US agent, US importer, FDA readiness and mock inspections, FDA inspections or other interactions with the FDA
• Customized in-house training on all of the above topics
• And many more

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.

Learn more about Regulatory Affairs

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.

Learn more about Quality Management Services

The initial situation must be known at the start of a project. This is the only way to assure an efficient planning and implementation! Axxos supports you with preparatory audits, as-is or gap analyses.

Learn more about Gap analysis and internal status audits

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.

Axxos has many years of experience in the development of medical devices. With clever registration strategies and customized processes, we ensure that design inputs, outputs, reviews, verification and validation are always traceable. However, we never lose sight of practicality and feasibility.