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.

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 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.

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.