ARTIFICIAL INTELLIGENCE - QUALITY AND REGULATORY REQUIREMENT

Humans have historically endeavored to innovate and shape processes that make life easy. Artificial Intelligence is changing our thought process, making us reconsider our technology choices, propelling us to re-design and change our processes in the most revolutionizing way possible. This unprecedented premise amidst the ‘new normal’ - post-pandemic social distancing, Work-From-Home -- is unparalleled.  Artificial Intelligence is introducing us to new tools and methodologies in which we have high expectation for their success. 

Artificial Intelligence in Medical science, Medical device, In-vitro Diagnostics, Clinical Evaluation, Healthcare, and even Pharma and Quality Systems software, is expected to be ranked among the top innovations of the decade. But what makes life easier, also is accompanied by many of issues and challenges for Manufacturers, Clinicians/Technicians, Engineers, QA/RA/Clinical professionals and Regulators globally.  As a consulting firm , we will focus on today and tomorrow’s regulatory environment and the challenges for manufacturers to design a compliant AI framework that is safe, effective and beneficial for human health and the global population. 

Key Consulting Area:

1. Regulatory framework of AI in US and EU 

2. AI based software classification 

3. Quality System and Good Machine Learning Practices (GMLP)