Introducing Regulatory Signals

Continuous regulatory awareness built around your Regulatory Positions

Every regulatory team monitors regulations.

Newsletters arrive every week. Regulatory authorities publish updates. Consultants share summaries. Regulatory intelligence platforms generate alerts.

Yet many organisations still struggle with the same problem.

The real challenge is rarely finding regulatory information. It is understanding whether a regulatory development is actually relevant to your products, your markets and the regulatory decisions you have already made.

As organisations expand into new markets and regulations continue to evolve, maintaining regulatory compliance becomes an increasingly continuous task rather than a one-time project.

Today, we're excited to introduce Regulatory Signals, a major new capability in Compliance Studio designed to help regulatory teams continuously maintain their Regulatory Positions as the regulatory landscape changes.

From regulatory monitoring to regulatory governance

Traditional regulatory monitoring answers one question:

"What has changed?"

Regulatory teams still need to answer the much harder questions:

• Does this affect us?

• Which products are impacted?

• Which markets are affected?

• Should we reassess an existing regulatory decision?

• What should we do next?

That work is still largely manual. Regulatory Signals was built to change that.

A practical example

Imagine a manufacturer marketing connected medical devices in both the EU and the United States.

One morning, the FDA publishes updated guidance affecting software validation. Later the same week, an amendment to the EU MDR introduces new expectations related to post-market surveillance.

Traditionally, those developments would arrive through different newsletters, monitoring services or consultants. Someone would then need to determine which products are affected, which regulatory decisions may need to be revisited and who within the organisation should act.

With Regulatory Signals, both developments appear in a single workspace. They are automatically linked to the relevant Regulatory Positions, accompanied by AI-generated summaries, governance assessments and suggested next steps.

Instead of searching for information, regulatory teams can immediately focus on deciding what matters.

Everything starts with a Regulatory Position

Compliance Studio is built around one central concept: the Regulatory Position.

A Regulatory Position defines the regulatory context for a specific product or organisation in a selected market. It forms the foundation for everything else within Compliance Studio.

Each Regulatory Position includes:

• A Regulations Register

• Continuous Regulatory Signals

• Studio Agent for AI-supported regulatory assessment

Rather than treating regulatory intelligence as a separate activity, Compliance Studio continuously connects new regulatory developments to the Regulatory Positions they may affect.

Try Compliance Studio and the new feature Regulatory Signals for free here