IVDR – In Vitro Diagnostics Regulations
Cellbytes is CE-marked, adhering to the EU 2017/746 IVDR, and available for use in EU countries. Cellbytes is not yet in the US for clinical use.
Commitment to security and quality
For Cellbytes, adhering to medical device requirements is fundamental to guarantee reliable performance and medical safety regulatory standards. We ensure uncompromised data security through advanced encryption and comprehensive privacy measures.
Compliance
ISO 13485:2016 – Medical Devices Quality Management
Outlines the requirements for a quality management system that ensures Cellbytes Ltd. can consistently deliver medical devices and related services that meet both customer expectations and regulatory standards.
HIPAA Security Rule & GDPR
Cellbytes is built on cloud services, designed to provide the highest level of security for medical data; featuring end-to-end encryption, firewalls, and multi-factor authentication. Patient information is securely protected throughout storage, processing, and transmission ensuring privacy across regions and borders.