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. 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

• Embrace/Embrace2
• Care Portal
• EmbracePlus and Empatica Care

Europe CE Marking certificate

• CE Certificate
• EpiMonitor powered by EmbracePlus declaration of conformity
• EpiMonitor by Empatica declaration of conformity
• EHMP (EmbracePlus + Care) declaration of conformity
• Care Portal declaration of conformity
• EmbraceMini EU Declaration of Conformity

United States - FDA 510(k) cleared

• K221282
• K172935
• K181861
• K230457
• K232915
• K242737
• K250515
• K252981

PRODUCT INSTRUCTIONS FOR USE

Manuals

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:

Embrace2 & Companion Apps

Empatica Health Monitoring Platform participant policy

EpiMonitor 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 website

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