dabl operates under a formally governed Quality Management System (QMS) compliant with ISO 9001:2015. Our certification confirms that our operational processes, risk controls, and information security practices are structured, regularly reviewed, and independently audited.

Our platform is developed and maintained in accordance with applicable regulatory requirements, including:

• 21 CFR Part 11 (FDA) for electronic records and electronic signatures
• EU GMP Annex 11 requirements for computerised systems
• Follows ICH-GCP E6 (R3) and ISO 14155 for device and high-risk studies
• Fluent in ISO 81060-2 blood pressure device validation

System development follows a documented validation lifecycle, incorporating risk-based validation, traceable requirements, controlled change management, and formal release approval. Comprehensive audit trails, role-based access controls, electronic signature functionality, and secure data handling processes support 21 CFR Part 11 and EU Annex 11 principles.

Information security and data protection are embedded throughout our operations. Data is encrypted in transit and at rest, access is restricted according to defined roles and responsibilities and unique login codes, and backup and disaster recovery procedures are regularly tested.

Where applicable, dabl operates in compliance with GDPR.