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. Our Certifications include:

• ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for regulatory purposes
• European Union Medical Device Directive (EU MDD) 93/42/EEC
• US FDA's Quality System Regulations (QSRs)

SO/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.

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

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 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 13189309
• 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.