Regulatory files and technical documentation
Compiling documents, checking consistency across them, tracking versions, drafting answers to authority questions: the agent prepares, regulatory affairs validate and sign.
Regulatory documentation, quality systems, technical support, monitoring: Claude agents that take document work off your teams, within the rules that govern health data and health products.
An AI agent for healthcare and life sciences is a Claude agent that handles document and support work at a pharmaceutical company, a medical device manufacturer or a care provider: regulatory files, quality system, technical support, monitoring. It makes no medical diagnosis and decides on no treatment.
In healthcare, the first question is intended purpose: an agent that touches care does not follow the same rules as an agent that prepares a file. Four frameworks show why.
Health data is a special category under Article 9 of the GDPR: processing it is prohibited except under the exceptions the text provides. An agent handling it requires a legal basis plus one of the Article 9 exceptions, an impact assessment and access limited to what is strictly necessary.
Some member states add hosting rules for health data. In France, hosting health data collected during prevention, diagnosis, care or follow-up on behalf of a third party requires an HDS-certified host. The architecture of an agent that touches such data has to account for it, down to the logs.
Software that its manufacturer intends for a medical purpose, such as diagnosis or therapeutic decision support, can be a medical device under Regulation (EU) 2017/745 (MDR). An agent that stays on administrative, documentation or product support tasks has no such purpose.
An AI system that is itself a medical device, or its safety component, and that goes through a notified body is high-risk under the EU AI Act, with obligations applying from 2 August 2028. Keeping the agent away from any medical purpose avoids falling into that regime.
Compiling documents, checking consistency across them, tracking versions, drafting answers to authority questions: the agent prepares, regulatory affairs validate and sign.
Writing and revising procedures, preparing corrective and preventive action reviews, analysing complaints to spot trends: the agent documents, the quality manager decides.
Technical questions from professionals about a product, an order or a procedure: the agent answers from validated documentation and hands anything outside that scope to an expert. That is the principle of the agent deployed at Edera, a custom dental prosthesis manufacturer, on its technical mailbox.
Publications, health authority recommendations, changes to standards: the agent flags what concerns your products and prepares a sourced summary for medical and regulatory teams.
The agent does not diagnose, does not recommend treatment and does not triage patients. That boundary, written down at scoping, shapes the rest of the regulatory analysis.
Pseudonymisation, upstream filtering, restricted access: the agent only sees what its task needs. When a use case requires no health data at all, the architecture guarantees it.
Regulatory file, answer to an authority, quality procedure: every document that commits the company is reviewed and signed by an authorised person, and the record of that approval is kept.
We start from your processes and your regulatory constraints to find the first agent worth building, and the framework that goes with it.