Information Security and Medical Device Regulations

“We develop and deliver medical devices. Our software – powered by artificial intelligence, is designed to be safe, effective, and secure for our customers and patients. We care deeply about protecting health information.”

Florian Akpakpa

Head of RAQA and Privacy Compliance Officer at Sonio

Sonio and Global Medical Device Regulations

United States of America

Sonio Detect is US FDA 510(k) cleared. Sonio Detect is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect views, detect anatomical structures within the views and verify quality criteria of the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. The 510(k) summary is publicly available here in FDA’s database.
Sonio Pro is US class I medical device and a “medical image communication device”. Sonio Pro is intended to help Healthcare Practitioners to make sure US screening exams are well performed.

European Union (EU)

Sonio Detect is a class IIa CE Marked medical device under EU Regulation 2017/745 (Notified Body: BSI, CE2797)
Sonio Pro is not a medical device in EU. Sonio Pro is intended to help Healthcare Practitioners to make sure ultrasound screening exams are well performed.

Other Geographies

Please contact us for information on Sonio’s device registrations in any country.

We proudly comply with the highest security and data protection standards

HIPAA

HIPAA privacy and security requirements

EU-GDPR

European Union General Data Protection Regulation

HDS

Using only cloud providers and services HDS certified

ISO 13485

Certified quality management system

SOC2

Type 2 compliant

Deployments

solated multi-region deployments so data never leaves your region (EU, US, etc)

Cybersecurity

Data encryption at rest and in transit

Web Application Firewall and intrusion detection

Zero-trust security mechanisms for internal infrastructure and data access

Flexible deployments – on Cloud-based, on Premise, or Virtual Private-Cloud.