With the MedTech Regulatory Calculator, developed jointly with Dataciders, the methodology is applied to this field for the first time.
A Rule is a Rule, Regardless of Who Issues It
International regulatory requirements in medical technology are constantly evolving. Anyone developing, modifying, or bringing a medical device to market must repeatedly assess whether and how a standard applies whenever a new product, product change, or regulatory update arises. In practice, evaluations under ISO 13485 (Quality Management for Medical Devices), ISO 14971 (Risk Management), FDA requirements, and the EU MDR demand extensive research across multiple referencing, complementary, and continually changing frameworks. Ultimately, this results in a decision that must be defended during an audit: why a specific evaluation was made, on which normative basis, and with what outcome.
Rulemapping is familiar with this structure from public legislation. A standard formulates conditions under which a specific consequence ensues; checking whether these conditions are met is called subsumption. The Rulemapping method is deliberately generalistic: it represents any type of rule set within the exact same structure, whether it is codified law or a private sector standard. An ISO standard or an FDA specification does not differ from a law in its underlying structure, but only in who issued it and who monitors compliance. Where a law binds a public authority, a compliance standard binds the manufacturer directly – the underlying evaluation logic remains identical. This forms the starting point for the MedTech Regulatory Calculator.
What the Regulatory Calculator Delivers
The Regulatory Calculator translates this evaluation logic into a digital rule set. It guides users step-by-step through approval and conformity assessments while continuously verifying how specific product features align with relevant authorization requirements, ISO standards, and regulatory provisions – such as the pre-amendment status of a product under FDA law. When a standard or regulation changes, the Calculator automatically checks which existing products are affected, replacing manual tracking of every regulatory update.
The core difference compared to traditional practices lies not just in speed, but in reproducibility. Given identical inputs, a rule-based assessment always yields the exact same documented, fully traceable result. The outcome is not the subjective interpretation of a single specialist, but a clear decision path that can be presented in an audit exactly as it was made. The Calculator is implemented step-by-step: alongside new products, specific product modifications, or individual regulatory updates, rather than as a disruptive overhaul of the entire Regulatory Affairs process. For Regulatory Affairs and Quality Management teams, this means faster assessments, reduced audit overhead, and greater planning certainty for certifications when standards change.
A Partnership Putting the Methodology to the Test
Rulemapping renders rule sets machine-executable – regardless of their domain. Which standards apply in medical technology, how they correlate, and where practical application extends beyond the raw text: this domain expertise is provided by Dataciders, backed by 25 years of regulatory experience and recognized as a leading Data & AI service provider in the 2025 Lünendonk ranking.
The Regulatory Calculator was developed collaboratively: as a Rulemap that translates Dataciders' regulatory expertise into a machine-executable evaluation structure. For Rulemapping, this marks its entry into a highly regulated industrial sector where manufacturers must self-prove compliance to authorities, clients, and internal auditors. A completely novel approach – precisely because the underlying method remains unchanged.
The Upcoming Webinar
Dataciders and Rulemapping will demonstrate how this functions in daily Regulatory Affairs and Quality Management operations during a one-hour live webinar on September 17, 2026: “Deciding Vigilance with Confidence – Translating Regulatory Requirements Automatically into Traceable Decisions” . Lutz Andersch (Dataciders) and Sascha Wolf (Rulemapping) will present the Regulatory Calculator using MDR, MDSAP (Medical Device Single Audit Program), and ISO requirements, while answering questions from the audience. Participation is free of charge.
Register here: dataciders.com/event/vigilance-sicher-entscheiden-17092026
