Artificial Intelligence

We can support you with taking a pro-active approach to the development and documentation of your medical devices including ML/AI algorithms with gap analyses, technical dossier audits, and custom SOPs tailored to meet the newest requirements and regulations, such as:  

Good Machine Learning Practice

the FDA Predetermined Change Control Plan for ML/ AI in medical devices 

the NIST Artificial Intelligence Risk Management Framework (AI RMF 1.0)  

the European Artificial Intelligence Act

Quality Management System requirements for medical devices containing AI 

- Risk Management requirements for medical devices containing AI (AAMI TIR 34971:2023) 

- E2E Software Lifecycle Process (IEC 62304) 

- Data Protection Regulations 

- Cybersecurity standards

- Computer System Validation 

Medical Devices

Medical Device Software

In-Vitro Diagnostic Devices

Combination Products