Quality Assurance (ISO)

ISO Certification

Throughout the accreditation process we have developed and implemented a robust quality management system which has enabled us to improve our overall performance and maintain a high level of quality in everything we do. ISO 9001 / 27001 / 13485 accreditation not only demonstrates our strong focus on providing our customers with the highest level of service possible, but also our commitment to investing in the latest technology and developments in our company.

To become ISO 9001 compliant, we underwent an evaluation process that included quality management system development, a management system documentation review/audit, and a full assessment.

The ISO Certification clearly demonstrates that we are applying definite and detailed procedures throughout our services and operations.

So, we can proudly state that Care Direct services are delivered with quality and transparency in mind.

Quality is at the heart of everything we do, and we continuously challenge ourselves to improve our services to meet or exceed the needs and expectations of our customers, while always complying with regulations and specifications.

tuv-austria
Management System for Services (QMS) via EN ISO 9001:2015
Certificate Registratotion 20001210006306
Management Systems for Medical Devices via EN ISO 13485:2016
Certificate Registratotion 20302210006308
Information security, Cybersecurity and Privacy protection via EN ISO 27001:2022
Certificate Registratotion 20201220006413

Certification for the Trade and Distribution of Medical Products

This certification (Ministerial Decision DΥ8δ/Γ.Π. οικ/1348/2004) pertains to the authorization and regulation of activities related to the trade and distribution of medical devices & products. It ensures compliance with all applicable legal and quality standards, safeguarding public health and promoting the safe and effective use of these products.

By obtaining this certification, businesses demonstrate their commitment to adhering to strict guidelines for the handling, storage, and delivery of medical devices. This contributes to the overall reliability of the supply chain and fosters trust among healthcare providers and patients.

Such certifications are essential for maintaining the highest standards in the medical industry, ensuring that all distributed products meet the required specifications and regulatory requirements.

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