Standards Mapping
We map intended use, technology, risk profile, and target markets to the standards and evidence your file actually needs.
Testing Management
Plan the testing your submission actually needs.
Testing gaps appear late, then consume the schedule.
Lab & Sample Strategy
We identify lab-readiness issues, sample assumptions, sequencing dependencies, and timing risks before testing starts.
Report Readiness
We review existing and planned reports for edition, scope, deviations, conclusions, and submission usability.
Service specification
Korea Testing Management
You get a clear testing strategy, deliverables, client-input list, working rules, and separation between planning, coordination, and test execution.
Request assessmentFor Korea, we map testing needs to MFDS, NIDS, or designated technical-document review expectations, Korea-accepted standards, KGMP dependencies, and local documentation needs.
Standards mapping, test matrix, evidence gap review, lab strategy, sequencing, and coordination plan.; Physical test execution, sample manufacturing, and report authoring unless separately scoped.
Test matrix with standards, evidence status, priority, owner, and recommended action.; Lab and timeline plan with sample, documentation, and sequencing assumptions.
Typically 2-4 weeks after complete intake.; Kickoff, document intake, standards mapping, draft plan, and review meeting.
Intended use, classification logic, design documents, risk file, existing reports, and sample availability.; Regulatory, QA, and engineering input for assumptions and decision points.
One consolidated feedback round on the plan after delivery.; Email or shared workspace for lab decisions and document control.
Fixed fee when device scope and inputs are clear.; Lab fees, retesting, protocol writing, and submission work are scoped separately.
Frequently Asked Questions
Common questions about medical device testing management.