Empatica’s constant and decisive efforts aim at ensuring the safety, effectiveness, and quality of its medical devices as well as providing products that meet customer and applicable statutory and regulatory requirements.
Empatica’s constant and decisive efforts aim at ensuring the safety, effectiveness, and quality of its medical devices as well as providing products that meet customer and applicable statutory and regulatory requirements. To maintain this level of quality and to increase tangible customer satisfaction, we rely upon the effective application of our quality management system. Our Certifications include:
UNI CEI EN ISO 13485:2021 quality management system certification
US FDA (21 CFR Part 820) compliance
We are fully compliant with the US FDA Quality System Regulation. View our Establishment Registrations on the FDA website
Read our Terms & Conditions
ISO/IEC 27001:2013 is a security management standard that specifies security management best practices and comprehensive security controls following the ISO/IEC 27002 best practice guidance. The basis of this certification is the development and implementation of a rigorous security program, which includes the development and implementation of an Information Security Management System (ISMS) which defines how Empatica manages security. This state-of-the-art international security standard specifies the following:
Your privacy is important to us, and we are committed to protecting it. Empatica has established policies and procedures to ensure your personal information is handled responsibly and in accordance with applicable data protection and privacy laws.
Please check our Privacy Policies:
Empatica Health Monitoring Platform participant policy
Empatica Health Monitoring Platform EpiMonitor policy
Empatica Health Monitoring Platform - Data Processing Agreement
Empatica takes great care in designing, developing, and manufacturing its medical devices with the highest safety standards. Our products have been developed and tested according to the requirements of the following international standards:
Empatica validates its regulated products to ensure they are compliant and fit for their intended use. We also work with researchers, scientists, data analysts, physicians, and clinical trial sponsors to assist them with leveraging our product documentation in their own validation objectives.
Our procedures and methods for computerized system validation, including hardware and software, are based on regulatory requirements and industry standards and guidance such as GAMP 5.
The following patents apply to the Empatica products listed below, or use thereof. This page is intended to serve as notice under 35 U.S.C. § 287(a).
CN ZL201480025005.8, CN ZL201530150916.0, HK 1219041, INT DM/087034, JP 1574467, JP 1574468, JP 1574469, JP 1574470, JP 1574471, JP 1574472, JP 1574473, JP 1574474, JP 6824608, US 10,506,944, US D760,395, US D867,599
CN ZL201480025005.8, HK1219041, JP 6824608, US 10,134,378, US 10,506,944, US 10,679,599
CN ZL201480025005.8, CN ZL202030228433.9, EP 007954854-0001 - 007954854-0005, HK1219041, JP 6824608, GB 90079548540001 0079548540005, US 10,134,378, US 10,506,944, US 10,679,599, US D934430
Other patents pending
This list of patents was last updated on May 27, 2022.
The following is a non-exhaustive list of Empatica’s trademarks. The absence of a product or service name or logo from this list does not constitute a waiver of Empatica’s trademark or other intellectual property rights concerning that name or logo.
This list of trademarks was last updated on September 5, 2022.
Do you want to talk to our compliance team?You can contact us via email at compliance@empatica.com
