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Certifications and accreditations
ISO/IEC 42001:2023 - Artificial intelligence - Management system
Tonic Easy Medical is among the first companies in Europe to be certified under the ISO/IEC 42001:2023 standard for AI management systems, issued by BSI (AIMS 817029). This certification sets international requirements for the safe, transparent, and responsible governance of AI, and applies to Tonic’s clinical AI copilot. It reinforces the company’s commitment to ethical and compliant AI in healthcare. The certificate can be verified via the official BSI validation portal.
ISO 13485:2016 – Medical devices – Quality management systems
Tonic Easy Medical is also certified under the ISO 13485:2016 ISO 13485:2016 standard for quality management systems for medical devices, issued by BSI (MD 800345). This certification ensures that all processes related to the design, development, validation, and continuous improvement of medical device software meet international standards for safety and regulatory compliance. The certificate can be verified via the official BSI validation portal.
MDR - EU Medical Device Regulation (Class IIa)
Tonic AI - specifically in supporting pharmacological treatment decision-making - along with Tonic’s medical calculators and scales, are CE-marked as Class IIa medical devices under the European Medical Device Regulation (MDR 2017/745), following assessment by BSI (MDR 800344). This certification confirms that these components meet the EU’s stringent requirements for safety, clinical performance, and reliability. The certificate can be verified via the official BSI validation portal.
EACCME Medical Accreditation
Tonic Easy Medical is accredited by the European Accreditation Council for Continuing Medical Education (EACCME), created by the Union Européenne des Médecins Spécialistes (UEMS) to raise and harmonize the standards of medical education across Europe. This accreditation ensures that the clinical content provided through Tonic is scientifically rigorous, developed by medical specialists, and completely free from commercial bias or conflicts of interest.
Earn 1 CME credit for every hour of active use on Tonic! Accredited content is clearly marked within the app and does not include any sponsored material.
Earn 1 CME credit for every hour of active use on Tonic! Accredited content is clearly marked within the app and does not include any sponsored material.
Tonic, made available at https://tonicapp.io/ and organised by Tonic Easy Medical, is accredited by the European Accreditation Council for Continuing Medical Education (EACCME) to provide the above CME activity for medical specialists. Each medical specialist should claim only those credits that he/she actually spent in the educational activity. The EACCME is an institution of the European Union of Medical Specialists (UEMS). Only those e-learning materials that are displayed on the UEMS-EACCME website have formally been accredited. Through an agreement between the European Union of Medical Specialists (UEMS) and the American Medical Association (AMA), physicians may convert EACCME credits to an equivalent number of AMA PRA Category 1 CreditsTM. Information on the process to convert EACCME credit to AMA credit can be found at www.ama-assn.org/education/earn-credit-participation-international-activities.