The Dual-System Architecture

Engineering a single ISO 13485 Quality Management System that satisfies both EU MDR/IVDR and Swiss MedDO/IvDO requirements without duplication.

A Unified Core, Divergent Paths

The prevailing assumption that EU and Swiss compliance require separate Quality Management Systems is a structural inefficiency. We design a singular, jurisdiction-agnostic QMS core that absorbs the nuances of both regulatory frameworks. This architecture ensures that your operational excellence is not fractured by administrative borders.

Our approach decouples the process of quality assurance from the validation of specific market entry. By establishing a robust, unified foundation, we enable a streamlined propagation of data to distinct authorities, eliminating redundant documentation and audit fatigue.

The Propagation Logic

In a dual-framework architecture, a single event—such as a design change or a non-conformance—is recorded once in the master QMS. From this single source of truth, the system intelligently routes the necessary evidence to the relevant authority:

For the EU (EUDAMED): The system generates the specific technical documentation and clinical evaluation reports required by the European Commission and Notified Bodies.
For Switzerland (swissmedic): The same core data is mapped to the specific annexes of the MedDO and IvDO, ensuring alignment with Swiss-specific transitional provisions.

Critical Distinction: Process vs. Product

While the QMS certifies the process of manufacturing and quality control (ISO 13485), the product validation remains jurisdiction-specific. Our architecture clarifies this boundary, ensuring that your Notified Body audits the unified system, while market authorization is pursued through parallel, synchronized tracks.

The Role of the Notified Body

For high-risk devices (Class C and D under MDR/IVDR), the involvement of a Notified Body (NB) is mandatory. In our dual-architecture model, we structure the engagement so that a single NB audit can serve as the primary evidence for both jurisdictions, provided the NB holds the requisite scope for both EU and Swiss recognition.

We guide manufacturers in selecting and preparing for an NB audit that maximizes coverage, reducing the number of on-site visits and the associated disruption to operations. This is not merely about compliance; it is about optimizing the cost of quality across your entire addressable market.