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.
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.
Do you want to talk to our compliance team?
You can contact us via email at compliance@empatica.com
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
MDSAP certificate
Empatica QMS is certified to be compliant with:
ISO 13485:2016
Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) – Full Quality Assurance Procedure
Canada: Medical Devices Regulations – Part 1 – SOR 98/282
United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D
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 27001:2022 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
EpiMonitor policy US in English
EpiMonitor policy Washington in English
EpiMonitor policy GB in English
EpiMonitor policy EU in Danish
EpiMonitor policy EU in German
EpiMonitor policy EU in English
EpiMonitor policy EU in Spanish
EpiMonitor policy EU in French
EpiMonitor policy EU in Swedish
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
AT 2967415, CA 2907426, CN ZL201480025005.8, CN ZL201530150916.0, CN ZL202110059768.6, DE 2967415, EP 2967415, ES 2967415, FR 2967415, GB 2967415, HK 1219041, IE 2967415, INT DM/087034, IT 2967415, JP 1574467, JP 1574468, JP 1574469, JP 1574470, JP 1574471, JP 1574472, JP 1574473, JP 1574474, JP 6824608, NL 2967415, US 10506944, US 11766187, US D760,395, US D867,599
E4 Issued Patents
AT 2948043, AT 2967415, AU 2014208391, AU 2017264977, CA 2907426, CN ZL 201810147665.3, CN ZL201480013880.4, CN ZL201480025005.8, CN ZL202110059768.6, DE 2948043, DE 2967415, EP 2948043, EP 2967415, ES 2948043, ES 2967415, FR 2948043, FR 2967415, GB 2948043, GB 2967415, HK 1219041, IE 2948043, IE 2967415, IT 1415506, IT 2948043, IT 2967415, JP 6438891, JP 6686108, JP 6824608, NL 2948043, NL 2967415, US 10134378, US 10285602, US 10506944, US 10679599, US 11389074, US 11766187, US 9833155
EmbracePlus Issued Patents
AT 2948043, AT 2967415, AU 2014208391, AU 2017264977, CA 2907426, CN ZL 201810147665.3, CN ZL201480013880.4, CN ZL201480025005.8, CN ZL202030228433.9, CN ZL202030228433.9, CN ZL202110059768.6, DE 2948043, DE 2967415, EP 007954854-0001, EP 007954854-0001, EP 007954854-0002, EP 007954854-0002, EP 007954854-0003, EP 007954854-0003, EP 007954854-0004, EP 007954854-0004, EP 007954854-0005, EP 007954854-0005, EP 2948043, EP 2967415, ES 2948043, ES 2967415, FR 2948043, FR 2967415, GB 2948043, GB 2967415, GB 9007954854-0002, GB 9007954854-0002, GB 9007954854-0003, GB 9007954854-0003, GB 9007954854-0004, GB 9007954854-0004, GB 9007954854-0005, GB 9007954854-0005, GB 90079548540001, GB 90079548540001, HK 1219041, IE 2948043, IE 2967415, IT 1415506, IT 2948043, IT 2967415, JP 6438891, JP 6686108, JP 6824608, NL 2948043, NL 2967415, US 10134378, US 10285602, US 10506944, US 10679599, US 11389074, US 11766187, US 11922915, US 9833155, US D934430, US D934430
EmbraceMini Patents
Patents pending
E4 Realtime Issued Patents
AT 2967415, CA 2907426, CN ZL201480025005.8 , CN ZL202110059768.6, DE 2967415, EP 2967415, ES 2967415, FR 2967415, GB 296741, HK 1219041 , IE 2967415, IT 2967415, JP 6824608, NL 2967415, US 10506944, US 11766187
E4 Manager Issued Patents
AT 2967415, CA 2907426, CN ZL201480025005.8 , CN ZL202110059768.6, DE 2967415, EP 2967415, ES 2967415, FR 2967415, GB 296741, HK 1219041 , IE 2967415, IT 2967415, JP 6824608, NL 2967415, US 10506944, US 11766187
E4 Connect Issued Patents
AT 2967415, CA 2907426, CN ZL201480025005.8 , CN ZL202110059768.6, DE 2967415, EP 2967415, ES 2967415, FR 2967415, GB 296741, HK 1219041 , IE 2967415, IT 2967415, JP 6824608, NL 2967415, US 10506944, US 11766187
Empatica Care Issued Patents
AT 2948043, AT 2967415, AU 2014208391, AU 2017264977, CA 2907426, CN ZL 201810147665.3, CN ZL201480013880.4, CN ZL201480025005.8, CN ZL202110059768.6, DE 2948043, DE 2967415, EP 2948043, EP 2967415, ES 2948043, ES 2967415, FR 2948043, FR 2967415, GB 2948043, GB 2967415, HK 1219041, IE 2948043, IE 2967415, IT 1415506, IT 2948043, IT 2967415, JP 6438891, JP 6686108, JP 6824608, NL 2948043, NL 2967415, US 10134378, US 10285602, US 10506944, US 10679599, US 11389074, US 11766187, US 11922915, US 9833155
Research Portal Issued Patents
AT 2967415, CA 2907426, CN ZL201480025005.8 , CN ZL202110059768.6, DE 2967415, EP 2967415, ES 2967415, FR 2967415, GB 296741, HK 1219041 , IE 2967415, IT 2967415, JP 6824608, NL 2967415, US 10506944, US 11766187
SDK E4 Issued Patents
AT 2967415, CA 2907426, CN ZL201480025005.8 , CN ZL202110059768.6, DE 2967415, EP 2967415, ES 2967415, FR 2967415, GB 296741, HK 1219041 , IE 2967415, IT 2967415, JP 6824608, NL 2967415, US 10506944, US 11766187
SDK EmbracePlus Issued Patents
AT 2948043, AT 2967415, AU 2014208391, AU 2017264977, CA 2907426, CN ZL 201810147665.3, CN ZL201480013880.4, CN ZL201480025005.8, CN ZL202110059768.6, DE 2948043, DE 2967415, EP 2948043, EP 2967415, ES 2948043, ES 2967415, FR 2948043, FR 2967415, GB 2948043, GB 2967415, HK 1219041, IE 2948043, IE 2967415, IT 1415506, IT 2948043, IT 2967415, JP 6438891, JP 6686108, JP 6824608, NL 2948043, NL 2967415, US 10134378, US 10285602, US 10506944, US 10679599, US 11389074, US 11766187, US 11922915, US 9833155
EpiMonitor App Issued Patents
AT 2967415, CA 2907426, CN ZL201480025005.8 , CN ZL202110059768.6, DE 2967415, EP 2967415, ES 2967415, FR 2967415, GB 296741, HK 1219041 , IE 2967415, IT 2967415, JP 6824608, NL 2967415, US 10506944, US 11766187
Other patents pending.
This list of patents was last updated on March 10, 2025.
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
Australia 2320394
China (People's Republic) 1335984
European Union 15415839
Int'l Registration - Madrid Agreement / Protocol 1335984
Italy 1512730
Italy 302016000047145
Korea, Republic of 1335984
Switzerland/ 1335984
United Kingdom UK00915415839
United States of America 5,499,800
Embrace
Int'l Registration - Madrid Agreement / Protocol 1318930
Japan 6738102
Switzerland/INTL 1318930
United Kingdom UK00801318930
United States of America 5375865
Empatica Logo
Australia/INTL 2320359
Australia/INT 2386878
China (People's Republic) 36539948
European Union (Community) 10746196
European Union (Community) 15415854
European Union (Community) 18845551
Int'l Registration - Madrid Agreement / Protocol 1353983
Int'l Registration - Madrid Agreement / Protocol 1749261
Italy 1512928
Italy 302016000047148
Italy 302023000035973
Japan/INTL 1353983
Switzerland/INTL 1353983
Switzerland/INTL 1749261
United Kingdom UK00910746196
United Kingdom UK00915415854
United Kingdom/INTL 1749261
United States of America/INTL 7,525,756
Empatica Care Logo
Australia/INTL 1762166
European Union (Community) 18910299
Int'l Registration - Madrid Agreement / Protocol 1762166
Italy 302023000119949
Japan/INTL 1762166
Switzerland/INTL 1762166
United Kingdom/INTL 1762166
This list of trademarks was last updated on March 31, 2025.
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 Academic & Basic Research plan only.
Click here to download vendor documentation