Empatica

Quality & regulatory

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

Canada - Medical Device Licence

Europe CE Marking certificate

United States - FDA 510(k) cleared

PRODUCT INSTRUCTIONS FOR USE

Manuals

TERMS & CONDITIONS

Read our Terms & Conditions

Information Security

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.

Privacy

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:

Safety

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

Validation

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.

Patents

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