Intended purpose, indications, product configuration, market sequence, regulatory route, and claims boundaries.
Regulatory Affairs
Regulatory affairs support for EU and U.S. MedTech.
CENIT supports medical-device, IVD, and SaMD teams when classification, route-to-market, evidence, technical documentation, or authority interaction needs to be structured before work moves forward.
Scope
Clarify the route before documentation expands.
CENIT helps define the intended use, market route, evidence gaps, and submission sequence before teams invest time in the wrong documentation path.
Existing technical, clinical, performance, risk, usability, cybersecurity, labeling, and QMS evidence mapped against the route.
What must be prepared, remediated, sequenced, reviewed, or held before Notified Body or FDA interaction.
Coverage
Regulatory affairs scope.
The engagement can be narrow or broad. Scope is defined before work starts, including responsibilities, deliverables, assumptions, and dependencies.
Regulatory strategy EU MDR/IVDR and FDA route planning, product positioning, route sequence, and decision records. Classification and pathway EU classification rationale, FDA product-code mapping, predicate considerations, and route selection. Technical and submission files Technical documentation structure, 510(k)/De Novo inputs, evidence maps, and response preparation. Software and connected devices SaMD, AI-enabled software, cybersecurity, IEC 62304, usability, and lifecycle evidence alignment.
EU and U.S.
Regulatory paths need different evidence logic.
EU MDR/IVDR and U.S. FDA routes often use overlapping evidence, but the structure, terminology, timing, and review expectations are not identical.
Classification, conformity-assessment route, GSPR evidence mapping, technical documentation, PMS/PMCF planning, EUDAMED/UDI considerations, and Notified Body response support.
Product-code and regulation mapping, submission route assessment, 510(k)/De Novo planning, QMSR implications, labeling/UDI considerations, and FDA question-response support.
SaMD and digital health
Software evidence has to match the claim and risk.
For SaMD, AI-enabled functions, connected devices, and cybersecurity-sensitive products, CENIT helps align the regulatory route with software lifecycle documentation, risk controls, verification, usability, and security expectations.
Regulatory position, software functions, user interaction, automation level, and claims that create review expectations.
Software architecture, risk controls, SOUP, verification, validation, release logic, and change-control boundaries.
Security documentation, threat considerations, usability evidence, labeling, and post-market monitoring expectations.
Deliverables
Common regulatory outputs.
Outputs depend on the regulatory question, product stage, and market route. Common examples include:
Market route, classification assumptions, claims boundaries, decision points, dependencies, and timing.
Prioritized gaps against MDR/IVDR, FDA submission expectations, QMSR, risk, usability, software, or cybersecurity needs.
Technical documentation or submission sections organized so reviewers can trace claims, risks, evidence, and responses.
Boundaries
Responsibilities that should be scoped separately.
Clear boundaries protect the project. Some work can be coordinated, but should not be implied unless it is explicitly included.
Procedure writing, implementation, training, internal audit, and QMS ownership should be scoped separately.
Clinical investigation operations, PMCF execution, statistics, and CRO management may require specialist partners.
Importer, distributor, legal representative, PRRC, and U.S. FDA Agent duties should be defined as separate role-based scope.
Working method
How a regulatory affairs engagement starts.
The first step is to define the regulatory question precisely enough to avoid unnecessary work and missed dependencies.
Product, intended use, market, claims, current evidence, QMS state, deadline, and decision pressure.
Route, assumptions, owners, document needs, review sequence, and where external specialists may be required.
Documentation, review, response preparation, authority interaction, handover, or ongoing regulatory support as agreed.
Next step
Clarify the route before the work becomes harder to unwind.
Bring the product type, intended market, claims, current evidence state, and the regulatory decision you need to make.