The healthcare system demands efficient and effective processes in hospitals, care homes and health institutions. The requirements are defined in many different ways and go beyond standards such as ISO9001 or ISO13485. Specific specialist knowledge and practical implementation are required. Whether in the reprocessing and sterilization unit, in the medical device department, in the entire hospital, in a nursing home or in an assisted living facility of an addiction institution – Axxos is your competent partner for practical and effective quality management systems.

Due to changes in legal requirements, the demands on healthcare facilities have increased massively in recent years. In its quality development objectives, the Federal Council requires healthcare facilities to operate a suitable quality management system in order to guarantee safe, effective and integrated patient care. Quality management systems not only comply with laws or standards. When implemented in practice, work processes become easier, less scattered and errors are recognized better.

In practice, one or more of the following elements are required:

• Setting up quality management systems in individual areas such as reprocessing unit for medical devices, medical device departments responsible for maintaining medical equipment, vigilance, procurement and / or for the entire healthcare facility / hospital
• Preparation for certification audits (e.g. ISO 9001 / ISO 13485)
• Gap analyses on the requirements of Swissmedic MedDO, GPA, GPI, various guidelines and guidance documents
• Support with the creation and review of documents such as management reviews, qualifications and validations, etc.
• Monitoring of legal acts and standards as a subscription

Axxos, with its many years of experience in the healthcare sector, provides support in all areas.

Both manufacturers and users of medical devices can be inspected by the authorities (Swissmedic, cantons) at any time. For hospitals, it should be noted that increased inspections by Swissmedic are to be expected. 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.
Axxos offers support in the following areas:

• GAP analysis regarding the relevant legal requirements (e.g. GPA / MedDO) to identify potential gaps
• Development of pragmatic and legally compliant solutions and support during the implementation.
• Preparation and active support during an inspection
• Supporting the follow-upactivities of such an inspection
• Ensuring the efficient and sustainable processing/elimination of identified deviations
• Supporting adequate communication with the authorities.

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.

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.

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.