Regulatory Intelligence & Custom RAG Solutions for MedTech Manufacturers
HD Regulatory AI is an advanced, primary-source grounded regulatory intelligence platform designed specifically for medical device and In Vitro Diagnostic (IVD) regulatory affairs (RA) professionals. It uses secure Retrieval-Augmented Generation (RAG) to eliminate hallucinations and provide precise, cited answers from complex legal texts such as FDA 21 CFR, EU MDR, IVDR frameworks, and official guidance documents.
Site visitors can test our foundational regulatory knowledge base by registering with an email address. To maintain service performance, public demo users receive 6 complimentary high-precision queries per day without text-chunk retrieval.
For organizations looking to scale their compliance operations, we build dedicated, single-tenant enterprise knowledge bases tailored specifically to your company. Our core enterprise offerings include:
We prioritize strict data confidentiality. Custom enterprise knowledge bases are deployed in secure, isolated environments ensuring that your company's proprietary submission drafts, official correspondence, and health authority feedback are never mixed with public data or used to train public foundation models.
If your team is interested in deploying a dedicated health authority feedback knowledge base or unlocking enterprise-grade regulatory intelligence, you can reach out directly via email at contact@hdregai.com.