Compliance

This page provides an overview of the regulations and standards that apply to our company and products.

We further explain how we implement these to ensure that we provide you with a solution that is compliant, safe, secure, and performs according to its specifications.

Regulatory approvals

European Union

Within the European Union, software used for diagnostic and triage purposes is considered a medical device and needs to comply with the European Medical Device Regulation (2017/745). 

All our products comply with the European Medical Device Directive (MDD) and they are transitioning to the new European Medical Device Regulation (2017/745) (MDR).

Under the European Medical Device Regulation, Avicenna.AI has appointed a person Responsible for Regulatory Compliance (PRRC). The role is currently executed by our Regulatory Manager, Stephane Berger.

United States, United Kingdom, Canada, Brazil, Australia

Our products are certified for use in the U.S. Market, United Kingdom, Canada, Brazil, Australia, and more.  

Please contact us if you want to know if we are registered in your country and the name of our authorized representative.

Global Standards

Regulators often accept ISO (worldwide), or EN (European) standards to demonstrate compliance against regulations. By implementing the standard and demonstrating compliance against it, vendors automatically comply with specific law sections. If the standards are recognized by legislators, they confirm in writing that these standards meet compliance with legislative requirements.

ISO 13485

The ISO 13485 documents the Quality System requirements for manufacturers of medical devices. It includes requirements for design and development, documentation control, resource management, management and measurement, analysis, and improvement.

MDSAP (Medical Device Single Audit Program)

The MDSAP allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities including Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA (Japan), and the US Food and Drug Administration (FDA).

Other standards

The CE marking for medical devices requires the implementation of many more standards. Our company and products thus comply with:

  • IEC 62304 – Software Lifecycle Processes
  • IEC 82304 – Product Safety Requirements for Health Software
  • ISO 14971 – Risk Management
  • ISO 15223 – Use of symbols on medical devices
  • IEC 62366 – Usability engineering

Privacy and data protection

GDPR EU and HIPAA Compliance

As our company processes personal data belonging to EU and US citizens, we must comply with the relevant privacy legislation (GDPR and HIPAA). Our company is bound to strict Data Processing Agreements with each customer. To better understand how we process your data through our website, contact forms, or email, read up on our Privacy and Cookie Policy.

Avicenna.AI has appointed a Data Protection Officer (DPO), Cyril Di Grandi, to help ensure that personal data is processed according to the requirements set out by the privacy legislation. 

Please contact support@avicenna.ai for obtaining the most recent copy of our Certificates.

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