Assessments
Objective evaluations, actionable reports and industry benchmarking
We prioritize what matters most
As an MD or IVD manufacturer, you know assessing your quality systems and technical documentation is a critical step in staying ahead of evolving global regulatory demands. However, you might struggle with fragmented legacy systems, incomplete technical files, or unclear readiness for MDR, IVDR, or FDA requirements. Without a clear, expert-led assessment, it’s easy to overlook key gaps, which leads to nonconformities, rejected submissions, or delayed certifications.
We help you gain clarity and confidence through focused, regulatory-grade assessments that identify critical compliance gaps and prioritize what matters most. Whether preparing for an MDR submission, updating a 510(k), or simply checking the health of your quality system, we guide you with objective evaluations, actionable reports, and industry benchmarking, so you know exactly where you stand and what to do next.
Satisfied Clients
Discover how we can help:
QMS GAP Assessments
We evaluate your Quality Management System against ISO 13485, MDR, IVDR, or FDA QSR requirements, identifying missing or outdated procedures, risk controls, and documentation.
Technical documentation GAP assessment (MDR / 510(K))
We assess your device files against MDR Annex II & III or FDA 510(k) expectations, highlighting gaps in device description, performance data, labeling, and clinical evidence.
Notified Body-like technical documentation review
We conduct a simulated NB-style review of your technical documentation, applying real-world scrutiny to ensure your submission meets completeness, traceability, and structure requirements.
MDR technical documentation completeness check
We perform a detailed completeness check to confirm your MDR files meet all required modules, GSPR coverage, PMS plans, and clinical evaluation elements—before submission to your Notified Body.
Inadequate assessments can lead to duplicated efforts, surprise findings during audits, or submission delays. Teams may spend months preparing documentation that falls short, wasting time and budget while putting approvals and revenue at risk.
Our regulatory specialists conduct thorough, targeted assessments designed to accelerate your readiness. We highlight what needs fixing, streamline your compliance planning, and help prevent unnecessary iterations or remediation loops, saving valuable time, avoiding costly mistakes, and enabling faster approvals.
Couldn't find your question?
Why is a GAP assessment important before MDR or FDA submission?
A GAP assessment identifies missing elements, inconsistencies, or misalignments early preventing rejection or major nonconformities during review.
What’s the difference between a GAP assessment and a mock review?
A GAP assessment finds what’s missing; a mock review simulates a formal audit or submission review process and tests the robustness of what’s already in place.
Can we request a technical file review specific to our device class or region?
Yes, we tailor each assessment based on your product type, risk class, and target market (EU MDR, FDA 510(k), etc.).
Will we receive a formal report with recommendations?
Absolutely. Every assessment includes a clear, structured report outlining gaps, risks, and prioritized corrective actions.