Ametris Compliance Center
Access detailed information regarding the quality, privacy, security, and validation of Ametris products and systems.
Quality and Regulatory
Ametris 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
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
510(k) Clearances
Safety
Ametris 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.
Data Privacy
Ametris complies with General Data Privacy Regulation (GDPR) and implements technological and organizational controls around data privacy and protection. Ametris 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.
Ametris 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
Security
Ametris has established technical and organizational controls to mitigate information security risks and protect against cybersecurity threats. For data storage, processing, and application services, Ametris leverages qualified cloud vendors: Microsoft Azure and Amazon Web Services. Ametris implements its shared security responsibilities when using these cloud service providers.
Validation
Ametris'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. Ametris 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 Ametris requirements.