Quality Management System
UNI CEI EN ISO 13485:2021 quality management system certification
US FDA (21 CR Part 820) compliance
We are fully compliant with the US FDA Quality System Regulation. View our Establishment Registrations on the FDA website
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 CR 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
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: www.empatica.com/privacy
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.
You can contact us via email at compliance@empatica.com