Relevant Industry International Standards

Disclaimer: The standards below are informative and for educational purposes only. BEAA does not take any consequential responsibility whatsoever resulting from partially or fully adopting these standards or their misuse. 

ISO 9001:2015 (general quality management system)

ISO 13485:2016 (quality management system for medical devices)

ISO/IEC 27001 (information security management)

IEC 60601 (product safety standards for medical devices)

ISO 14971:2019 (application of risk management to medical devices)

GDPR (General Data Protection Regulation)