A systematic review of your existing documentation and testing against current regulatory requirements — with a clear, prioritized path to compliance.
A regulatory Gap Analysis is a systematic review comparing your medical device's existing documentation, testing, and quality processes against current regulatory requirements — such as EU MDR, FDA 21 CFR, or ISO standards.
This service identifies deficiencies, outdated data, missing test reports, or non-compliant processes, and provides a clear action plan with prioritized recommendations to achieve or maintain regulatory compliance.
Auditing your existing technical file against current requirements.
Identifying outdated, missing, or insufficient test reports.
Comparing your file against EU MDR, FDA 21 CFR, or ISO standards.
A ranked roadmap for closing every identified gap.
We review your existing documentation, testing, and quality processes.
Your file is compared against the applicable regulatory framework.
Missing data, outdated reports, and non-compliant processes are flagged.
A prioritized, actionable roadmap is delivered with clear next steps.
A clear, itemized list of documentation and testing gaps.
A prioritized action plan ranked by regulatory risk.
A direct comparison against your target framework (MDR, FDA, ISO).
Ongoing support as you close each identified gap.
Talk to our regulatory and scientific experts today.
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