Case Study
Digital Trust

Tonic Easy Medical: building trust in clinical AI

Certified to ISO/IEC 42001, ISO 13485 and MDR Class IIa technical assessment.

“ISO/IEC 42001 certification reflects our focus on quality and regulatory rigour.”

Cristiana Oliveira Quality and Compliance Manager, Tonic Easy Medical

“Physicians can trust our system to provide guidance that is reliable, accurate, and transparent.”

Cristiana Oliveira Quality and Compliance Manager, Tonic Easy Medical

“By taking a regulatory-by-design approach…we matured faster as an AI-first company.”

João Guichard Chief AI Officer, Tonic Easy Medical

The People

Tonic Easy Medical, is an EU-based, fast-growing clinical AI platform.

Currently serving 200,000+ physicians, Tonic needed to strengthen AI governance and achieve ISO/IEC 42001 & MDR Class IIa technical assessment.

The Challenge

As Tonic’s goal was multi-faceted, it needed credible, third-party validation and an integrated management system for quality and AI.

The combination of a desire for improved governance, operational maturity and supporting safe, scalable growth into new markets, including the UK and Germany, gave the project a clear focus.

The Tonic team had to balance rapid product development with tight regulatory timelines, ensuring risk management, documentation, and audit readiness while usage grew at pace.

The Solution

BSI delivered a thorough but constructive audit programme of Tonic’s AI management system against ISO/IEC 42001 and MDR expectations and benchmarks.

Auditors applied a risk-based approach, with clear communication and practical feedback. Tonic was then enabled to integrate its AI management system into its QMS.

The collaborative experience with BSI improved Tonic’s internal traceability and governance. Additionally, a key positive experience was within the Tonic development team and how they approached the fast-paced of change in the AI landscape and what that means specifically for their product RND.

These experiences combined to provide Tonic the opportunity to align their expectations and schedule to time-to-market.

Tonic achieved AI and MDR certifications for its AI copilot.

Certifications for ISO 13485, ISO/IEC 42001 and MDR Class IIa technical assessment.
The certifications support trust with clinicians and stakeholders.
Strengthen oversight and post-market surveillance.
Provide a roadmap for continuous improvement as engagement with the copilot accelerates.

Tonic is well placed to continue leading in clinical AI.

200,000+

Physicians supported across France, Italy, Spain and Portugal.
11.3 million

Clinician queries in 2025.
+458%

Year-on-year growth in clinician queries (2025).
+305%

Increase in power users (2025).

Why BSI?

Tonic valued BSI’s professionalism, clear guidance, and market credibility.

BSI was a solid choice for Tonic and their certification journey shows how strong governance and responsible innovation can work together.

Our reputation in SaMD and AI, alongside our depth of expertise, audit consistency, and capacity to start at pace made the collaboration a positive working project, with excellent outcomes.

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