Regulatory and Global Standards
In a global landscape where healthcare holds an primary position, the imperative to guarantee safety, security, and accuracy takes on crucial importance.
Our commitment to upholding the highest standards of compliance reflects our dedication to providing solutions that prioritize safety, security, and precise performance.
Our dedication extends to the health and well-being of patients, the integrity that underlies medical procedures, and the seamless fusion of technology to drive positive change.
Explore the comprehensive scope of regulations and standards that encompass our company and products.
Regulatory Requirements
Within the European Union, software employed for diagnostic and triage purposes is categorized as a medical device, necessitating adherence to the European Medical Device Regulation (2017/745).
We take pride in confirming that all our tools align with the European Medical Device Directive (MDD) and are undergoing the transition to the new European Medical Device Regulation (2017/745) (MDR).
To guarantee compliance with the European Medical Device Regulation, Avicenna.AI has designated a dedicated person responsible for regulatory compliance (PRRC), currently fulfilled by our Regulatory Manager, Stephane Berger.
Our products also have obtained certification for utilization in the U.S. market, United Kingdom, Canada, Brazil, Australia, and other regions.
If you seek information regarding our registration in your country or the identity of our authorized representative, please don’t hesitate to get in touch.
Global Standards
Regulatory bodies frequently acknowledge ISO (international) or EN (European) standards as valid benchmarks for demonstrating compliance.
By integrating these standards, compliance with specific legal sections can be achieved when recognized by legislative bodies.
ISO 13485
ISO 13485:2016 delineates the Quality System prerequisites for manufacturers of medical devices, encompassing aspects such as design, development, installation, resource management, measurement, and improvement.
Our adherence to ISO 13485:2016 ensures the production of high-caliber products that align with the highest requirements in the medical device industry.
MDSAP
Medical Device Single Audit Program (MDSAP) streamlines regulatory audits of medical device manufacturers’ quality management systems to fulfill the demands of multiple authorities.
This includes the 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
Beyond ISO 13485 and MDSAP, our company and products conform to a range of standards indispensable for securing the CE marking of medical devices. These encompass:
- IEC 62304:2006/Amd 1:2015 – Software Lifecycle Processes
- IEC 82304-1:2016 – Product Safety Requirements for Health Software
- ISO 14971:2019 – Risk Management
- ISO 15223-1:2021 – Use of symbols on medical devices
- IEC 62366-1:2015 – Usability engineering