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.

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.

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.

With the Medical Device Regulation (EU) 2017/745 (MDR), the basic requirements for medical devices have become stricter. In addition, there are new specifications, structures and required content for the technical documentation. This is true for both, products that have been on the market for a long time (legacy products) or newly developed devices.

Our experts at Axxos provide support for all challenges and bring a wealth of experience from all areas and risk classes of medical devices. Competent advice, MDR-specific documentation review or a clever registration strategy – we provide uncomplicated, pragmatic help exactly where it is needed.

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

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

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.

There are many applicable laws, standards and guidance documents in the medical device industry. The Axxos update service monitors and summarizes the changes in a comprehensible annual or semi-annual report.