Compliance Studio is now live
- Team Hoodin
- Mar 26
- 2 min read
Determining regulatory scope has always been a foundational task in Regulatory Affairs. It concerns which regulations apply to a given product, across which markets, and how that evolves over time.
In practice, this has rarely been established as a stable construct. Instead, it is built and maintained through a combination of regulatory interpretation, internal documentation, and accumulated experience.
This approach can function operationally. However, it introduces recurring challenges. Regulatory scope must be continuously reconstructed, interpretations may vary between teams, traceability is often limited, and uncertainty persists regarding completeness and correctness.
Compliance Studio was developed to address this specific problem
Rather than treating regulatory information as documents to be searched or monitored, the system treats regulatory scope as a structured and continuously maintained entity.
A product is defined through a set of attributes. Based on this, the system determines which regulations apply across selected markets.
For example, consider a connected medical device with embedded software distributed in the EU, UK, and Switzerland.
From that starting point, the system establishes regulatory scope. It identifies applicable regulations such as EU MDR, its UK implementation, and the corresponding Swiss framework. These are not presented as isolated entries, but as related regulatory structures, where alignment and variation across jurisdictions are made explicit.
For each regulation, the system provides a structured set of key regulatory points, identifies areas where requirements differ between markets, and links directly to official sources and regulatory bodies.
Regulatory updates are interpreted in context. Rather than presenting updates as standalone information, the system relates them to the defined regulatory scope, enabling an assessment of relevance and potential impact.
Over time, the system maintains this structure. Regulatory scope is not repeatedly rebuilt, but continuously kept current.
This is enabled by structuring the regulatory landscape itself and applying a controlled reasoning layer on top of that structure. It is not achieved by applying AI to regulatory text in isolation.
The approach is applicable across core life science domains. It supports medical devices, in vitro diagnostics, pharmaceuticals, and combination products, where regulatory scope depends on product characteristics, intended use, and market selection.
Each determination within the system can be explained, traced, and reviewed. This supports use in regulatory environments where documentation and accountability are required.
The objective is not to simplify regulation. It is to provide a more consistent way of structuring and maintaining regulatory scope over time.
Compliance Studio is now live!
Explore how it works in practice and evaluate the system in your own regulatory context.
A freemium version is available.