Four short, scored questionnaires that show you where your MDR, IVDR, EU AI Act or FDA readiness stands, before you spend money on a formal review.
A compliance self-assessment is a short questionnaire you score yourself against known MDR, IVDR, EU AI Act or FDA checkpoints. It takes minutes rather than weeks and returns a prioritised list of gaps, without a Qserve auditor reviewing a single page of your file.
It won't catch what a trained reviewer finds inside your actual technical documentation. What it will do is tell you which of five to seven areas needs attention first, so the conversation with a specialist starts from a shortlist instead of a blank page.
A self-assessment is free, self-scored, and finished in minutes. A gap assessment is an expert-led review of your actual technical documentation or QMS, run by a regulatory specialist, that produces a formal report with a defensible remediation plan. Run the self-assessment first. Escalate to a gap assessment once you need the file-level detail a questionnaire cannot see.
Both sit under our wider Audits & Assessments work, which also covers supplier and Notified Body mock audits for teams already past the self-check stage.
We offer four free self-assessments for medical device and IVD teams, and the right one depends on what is due next. Early-stage companies start with the startup quiz. Manufacturers preparing a filing, a clinical evaluation, or an AI-enabled device pick the matching tool below. Each takes two to five minutes and ends with a prioritized list of gaps.
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The Medtech Startup Regulatory Readiness Quiz is a seven-question self-assessment for early-stage medical device companies planning for the EU and US markets. The questions follow the order in which regulatory foundations usually need to be in place: first market, intended purpose, device classification, quality management system, risk management, design controls, and clinical evidence. It shows what to fix first, before a gap becomes rework.
The CE Submission Readiness Quiz is a seven-question self-assessment covering EU MDR 2017/745 and IVDR 2017/746 in a single flow. It checks device classification, QMS alignment, technical documentation, clinical or performance evidence, Notified Body engagement, post-market surveillance, and EUDAMED and UDI registration. You get a percentage readiness score and a list of which gate to close first.
The Clinical Evaluation Readiness Check is a six-question self-assessment covering the Clinical Evaluation Plan, Clinical Evaluation Report, and post-market clinical follow-up that EU MDR requires. It flags whether your CEP scope, literature search, benefit-risk conclusion, and PMCF update cycle would survive Notified Body scrutiny.
The QMS AI Readiness Quiz is a five-question self-assessment that checks your quality management system against the EU AI Act and the Team-NB AI questionnaire Notified Bodies are starting to apply. It covers AI-specific risk management, data governance, human oversight, and documentation, areas ISO 13485 does not address on its own.
Following the Digital Omnibus amendment adopted in 2026, high-risk AI embedded in a medical device or IVD now has until 2 August 2028 to meet the AI Act's full obligations, later than the original 2027 date. That later deadline is a reason to plan properly, not a reason to wait to find out where your gaps sit.
Answer each question with the option that matches your current state, not your target state. The tool scores every answer against four bands, from best practice to critical gap, and combines the weighted results into a single readiness percentage. At the end you'll see your score, a plain-language explanation for each gap it found, and a link to talk to a specialist about the ones that matter most. Nothing you enter is reviewed by a person unless you ask us to follow up.
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Know if your device needs a clinical investigation under MDR, and how ISO 14155:2026 shapes the study. Learn the exemptions, pitfalls and next steps.
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Missing the 28 November EUDAMED deadline puts your devices at risk of non-compliance. Learn what’s at stake and how to get your data submitted in time.
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Learn how to structure a PMCF plan under the EU MDR. Walk through sections A to G of MDCG 2020-7 and avoid four common pitfalls before your Notified Body does.