Legal & Compliance
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.
QUALITY MANAGEMENT SYSTEM
UNI CEI EN ISO 13485:2021 quality management system certification
US FDA (21 CFR Part 820) compliance
PRODUCT CERTIFICATIONS AND APPROVALS
Australia - Devices listed in ARTG
Europe CE Marking certificate
United States - FDA 510(k) cleared
PRODUCT INSTRUCTIONS FOR USE
TERMS & CONDITIONS
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:
Empatica systematically evaluates its information security risks, taking into account the impact of threats and vulnerabilities.
Empatica implemented an overarching Information Security Management process to ensure that the information security controls meet internal and external needs.
This certification is performed by independent third-party auditors. Empatica's compliance with these internationally-recognized standards is evidence of our commitment to information security at every level of our organization, and that Empatica's security program is in accordance with industry-leading best practices.
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:
ISO 14971:2019 - Medical devices — Application of risk management to medical devices
IEC 60601-1:2005/A1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6:2010 + AMD1:2013 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 60601-1-11:2015 - Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
FCC Rules: Code of Federal Regulations (CFR) no. 47, Part 15 Subpart C Section 15.247
ETSI EN 301 489-17 V3.2.4 (2020-09)
ETSI EN 300 328 V2.2.2 (2019-07)
IEC 62304:2015 - Medical device software - Software life cycle processes
IEC 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-10:2010 - Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
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).
Embrace2 Issued Patents
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
E4 Issued Patents
AT 2948043, AU 2014208391, AU 2017264977, CN ZL201480013880.4, CN ZL201480025005.8, CN ZL201810147665.3, DE 2948043
ES 2948043, FR 2948043, GB 2948043, HK 1219041, IE 2948043, IT 1415506, IT 2948043, JP 6438891, JP 6686108, JP 6824608, NL 2948043, US 9,833,155, US 10,134,378, US 10,285,602, US 10,506,944, US 10,679,599
EmbracePlus Issued Patents
AT 2948043, AU 2014208391, AU 2017264977, CN ZL201480013880.4, CN ZL201480025005.8, CN ZL201810147665.3, CN ZL202030228433.9, DE 2948043, EM 007954854-0001 - 007954854-0005, ES 2948043, FR 2948043, GB 2948043, GB 90079548540001 0079548540005, HK 1219041, IE 2948043, IT 1415506, IT 2948043, JP 6438891, JP 6686108, JP 6824608, NL 2948043, US 9,833,155,
US 10,134,378, US 10,285,602, US 10,506,944, US 10,679,599, US D934430
E4 Realtime Issued Patents
AT 2948043, AU 2014208391, AU 2017264977, CN ZL201480013880.4, CN ZL201810147665.3, DE 2948043, ES 2948043, FR 2948043, GB 2948043, IE 2948043, IT 2948043, IT 1415506, JP 6438891, JP 6686108, NL 2948043, US 9,833,155, US 10,134,378, US 10,285,602, US 10,679,599
E4 Manager Issued Patents
AT 2948043, AU 2014208391, AU 2017264977, CN ZL201480013880.4, CN ZL201810147665.3, DE 2948043, ES 2948043, FR 2948043, GB 2948043, IE 2948043, IT 1415506, IT 2948043, JP 6438891, JP 6686108, NL 2948043, US 9,833,155, US 10,285,602
E4 Connect Issued Patents
AT 2948043, AU 2014208391, AU 2017264977, CN ZL201480013880.4, CN ZL201810147665.3, DE 2948043, ES 2948043, FR 2948043, GB 2948043, IE 2948043, IT 2948043, IT 1415506, JP 6438891, JP 6686108, NL 2948043, US 9,833,155, US 10,134,378, US 10,285,602, US 10,679,599
Empatica Care Issued Patents
AT 2948043, AU 2014208391, AU 2017264977, CN ZL201480013880.4, CN ZL 201810147665.3, DE 2948043, ES 2948043, FR 2948043, GB 2948043, IE 2948043, IT 2948043, IT 1415506, JP 6438891, JP 6686108, NL 2948043, US 9,833,155, US 10,134,378, US 10,285,602, US 10,679,599
Research Portal Issued Patents
AT 2948043, AU 2014208391, AU 2017264977, CN ZL201480013880.4, CN ZL 201810147665.3, DE 2948043, ES 2948043, FR 2948043, GB 2948043, IE 2948043, IT 1415506, IT 2948043, JP 6438891, JP 6686108, NL 2948043, US 9,833,155, US 10,134,378, US 10,285,602, US 10,679,599
SDK E4 Issued Patents
AT 2948043, AU 2014208391, AU 2017264977, CN ZL201480013880.4, CN ZL 201810147665.3, DE 2948043, ES 2948043, FR 2948043, GB 2948043, IE 2948043, IT 2948043, JP 6438891, JP 6686108, NL 2948043, US 9,833,155, US 10,134,378, US 10,285,602, US 10,679,599
SDK EmbracePlus Issued Patents
AT 2948043, AU 2014208391, AU 2017264977, CN ZL201480013880.4, CN ZL 201810147665.3, DE 2948043, ES 2948043, FR 2948043, GB 2948043, IE 2948043, IT 1415506, IT 2948043, JP 6438891, JP 6686108, NL 2948043, US 9,833,155, US 10,134,378, US 10,285,602, US 10,679,599
Other patents pending.
This list of patents was last updated on February 11, 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.
Empatica
European Union 015415839
China (People's Republic)/INTL 1335984
Int'l Registration - Madrid Agreement / Protocol 1335984
Japan/INTL 1335984
Korea, Republic of/INTL 1335984
Switzerland/INTL 1335984
Italy 362022000010760
Italy 302016000047145
United States of America/INTL 5,499,800
United Kingdom UK00801318930
United Kingdom UK00915415839
Embrace
European Union INTL 1318930
Int'l Registration - Madrid Agreement / Protocol 1318930
Switzerland/INTL 1318930
Australia/INTL 1809689
United States of America 5,375,865
Empatica Logo
European Union 015415854
China (People's Republic)/INTL 1353983
Int'l Registration - Madrid Agreement / Protocol 1353983
Japan/INTL 1353983
Korea, Republic of/INTL 1353983
Switzerland/INTL 1353983
Italy 302016000047148
China (People's Republic) 36539948
United States of America/INTL 5,430,535
United Kingdom UK00915415854
European Union 010746196
Italy 362022000010739
United Kingdom UK00910746196
This list of trademarks was last updated on September 5, 2022.
To assist our academic customers in completing their vendor qualification form for the Empatica Health Monitoring Platform, we have prepared a detailed documentation pack.
This information can be used to facilitate your organization’s review and approval process. Please note the information contained is relevant to the Professional plan only.
Click here to download vendor documentation
Do you want to talk to our compliance team?
You can contact us via email at compliance@empatica.com