ActiGraph Compliance Center

ActiGraph is committed to ensuring the safety, effectiveness, and quality of our products. Our Quality Management System (QMS) conforms with the requirements of the ISO 13485:2016 international standard established to ensure that medical devices are consistently high quality throughout their lifecycle, from design to disposal, to meet regulatory requirements and customer needs.

Compliance with global regulatory standards is assured by our participation in the Medical Device Single Audit Program (MDSAP) since 2018, with annual surveillance audits conducted by a recognized independent Auditing Organization (AO).

Our QMS certification includes the following applicable regulatory standards:

• Australian Therapeutic Goods Administration Medical Devices Regulation (TGA MDR)
• European Union Medical Device Regulation (EU MDR)
• Health Canada Medical Devices Regulations (CMDR)
• US FDA's Quality System Regulations (QSRs) - 21 CFR Part 820

QMS Certificates

• ISO 13485:2016 / MDSAP Certificate
• EN ISO 13485:2016 Certificate

Australia

• ARTG Public Listing 320859

Canada

• Health Canada License 102376

Europe EU CE Mark

• Declaration of Conformity (LEAP)
• Declaration of Conformity (CPIW)
• Declaration of Conformity (wGT3X-BT)

Our EU CE Mark DoCs declare the products meet the provision of the following EU legislation:

• Medical Device Regulation, MDR (EU) 2017/745
• Radio Equipment Directive (RED) 2014/53/EU
• Restriction of the use of certain hazardous substances (RoHS) Directive 2011/65/EU

UK

• UK MHRA Registration 32485

US FDA

• ActiGraph's FDA Registration

510(k) Clearances

• K231532 - LEAP
• K181077 - CentrePoint Insight Watch (CPIW)
• K080545 - GT9X, wGT3X-BT
• K040554 - AM7164 (2004, inactive)

ActiGraph applies risk management throughout the total product life cycle to ensure safety. Our product realization conforms to following key internationally recognized consensus standards appropriate for the evaluation of medical device safety and effectiveness:

• ISO 14971:2019 Medical devices - Application of risk management to medical devices
• ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
• IEC 60601-1-11 Basic Safety and Essential Performance for Medical Device to be used in Home Healthcare

Additional certifications for wireless components, batteries, and environmental standards can be found in the Instructions for Use (IFU) for each product and also upon request.

ActiGraph complies with General Data Privacy Regulation (GDPR) and implements technological and organizational controls around data privacy and protection. ActiGraph will support customers in meeting their GDPR requirements with data processing agreements that include the standard contractual clauses (SCCs) regarding data processing, control, and transfer.

ActiGraph complies with EU-U.S. Data Privacy Framework (EU-U.S. DPF), the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. Data Privacy Framework (Swiss-U.S. DPF) as set forth by the U.S. Department of Commerce.

View ActiGraph’s Full Privacy Policy

ActiGraph has established technical and organizational controls to mitigate information security risks and protect against cybersecurity threats. For data storage, processing, and application services, ActiGraph leverages qualified cloud vendors: Microsoft Azure and Amazon Web Services. ActiGraph implements its shared security responsibilities when using these cloud service providers.

ActiGraph’s design validation confirms by examination and objective evidence that the device’s design is capable of consistently fulfilling the requirements for the specified application or intended use. ActiGraph procedure for validating computerized systems is based on “GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems” and “FDA Guidance for Industry: Computerized Systems used in clinical investigations.” The system validation demonstrates through documented evidence that a system is reliable, fit for its specified purpose, and compliant with regulatory and ActiGraph requirements.