End-to-end regulatory strategy, documentation, and compliance for medical devices, SaMD, and digital health innovations — from first classification to multi-market approval.
MDR Transition Deadlines: EU MDR grace periods are expiring on a rolling basis through 2028. Legacy MDD/AIMDD certificates may no longer be accepted. Contact us for a transition readiness assessment.
A structured six-phase pathway covering every step from initial gap analysis to post-market obligations.
Review existing documentation and identify compliance gaps against target regulatory framework.
Build or remediate a Quality Management System aligned to ISO 13485, FDA 21 CFR Part 820, or EU MDR Annex IX.
Compile technical documentation: design history, risk management (ISO 14971), clinical evaluation, and labelling.
Support clinical evaluation reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and systematic literature reviews.
Manage Notified Body audit preparation, MHRA registration, EUDAMED, UDI, and FDA 510(k) / PMA submission packages.
Establish PMS system, Periodic Safety Update Reports (PSURs), vigilance reporting, and complaint handling procedures.
Click any service to expand the full scope of work we provide.
We support simultaneous submissions across all major healthcare markets.
Select your pathway and track progress through every milestone, deadline, and required document.
Interactive milestone-by-milestone pathway
Timeline Summary
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Our regulatory experts are ready to assess your device, map your compliance pathway, and deliver a clear roadmap to market approval — fast.
Tell us about your project and we'll adapt our approach to fit.