A paper containing various ISO-standard registration marks.

Commitment to security and quality

Only by adhering to medical device requirements can we guarantee reliable performance and medical safety regulatory standards. Our CE-marked Cellbytes software complies with globally recognized quality certifications and the IVDR.

The Cellbytes team and platform adhere to data privacy regulations such as HIPAA and GDPR. We ensure uncompromised data security through advanced encryption and privacy measures.

Compliance

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ISO 13485:2016 – Medical Devices Quality Management

Outlines the requirements for a quality management system that ensures an organization can consistently deliver medical devices and related services that meet both customer expectations and regulatory standards. Organizations adhering to this standard may be involved in various stages of the device life cycle, including design and development, production, storage and distribution, installation, servicing, or providing associated activities such as technical support.