CLINICAL EVALUATION
No Blind Spots. No Surprises.
Clinical Evidence that Stands Up to Scrutiny
No sales pitch - leave with a clear path forward
We help MedTech manufacturers prepare clinical evidence that satisfies EU MDR & UK MDR requirements; not just on submission day, but throughout your product's lifecycle. Whether you're facing an upcoming audit, managing an overwhelmed team, or need a partner who understands what "rigorous" actually means, we provide the evidence strategy and documentation that keeps you compliant and confident.
Why Clinical Evaluation Matters
The cost of getting it wrong is not theoretical:
Audit Failures Delay Market Access
Notified Bodies routinely flag Clinical Evaluation Reports for insufficient evidence, forcing manufacturers into costly remediation cycles that can push timelines back 6-12 months.
Compliance Gaps Compound Over Time
A missing literature review or inadequate post-market data today becomes a critical finding tomorrow. Many manufacturers don't discover these gaps until an auditor points them out.
Small Teams Can’t Keep Up
MDR's clinical evidence requirements demand specialised expertise and significant time, resources most regulatory teams simply don't have. The result: rushed documentation, incomplete analyses, and increased risk.
If you're responsible for regulatory compliance, you already know that Clinical Evaluation is where many MDR projects stall. You need a partner who finds the gaps before regulators do.
Worried this is you?
We’ll identify the top three exposure points and next steps
SciMed’s Clincial Evaluation Services
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Complete, Cross-Referenced Clinical Evidence Package That Passes Notified Body Scrutiny
A Clinical Evaluation Documentation Suite is the complete set of integrated regulatory documents required to demonstrate your medical device's clinical safety and performance under EU MDR Article 61 and Annex XIV. This includes your Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), and State-of-the-Art review - all written by the same expert team to ensure internal consistency and cross-referencing that withstands audit.
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Strategic Evidence Roadmap That Prevents Costly Last-Minute Clinical Studies
A Clinical Development Plan (CDP) is a strategic roadmap defining what clinical evidence your medical device needs, how you'll generate it, when you'll collect it, and how it supports your chosen regulatory pathway - ideally created during design and development when you still have degrees of freedom to influence timelines, costs, and study design. It prevents the expensive mistake of discovering critical evidence gaps six months before your planned market launch.
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Systematic Literature Analysis That Anchors Your Benefit-Risk Justification
A State-of-the-Art (SotA) review is a systematic, protocol-driven analysis of current medical knowledge and existing treatment options for your device's clinical indication. Under MDR Annex XIV, it establishes the performance and safety baseline your device must achieve or exceed - and provides the comparator data that anchors your benefit-risk analysis in the Clinical Evaluation Report. It's not a PubMed search summary. It's a defensible evidence synthesis using transparent methodology.
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Protocol-Driven Methodology That Proves Your Clinical Evaluation Was Systematic, Not Ad-Hoc
A Clinical Evaluation Plan (CEP) is a protocol document defining your strategy for demonstrating clinical safety and performance under MDR Article 61. It specifies what evidence you'll use (literature, clinical data, equivalence), what acceptance criteria must be met, how you'll analyse that evidence, and how Clinical Evaluation integrates with risk management - all documented before you conduct the evaluation. It's the regulatory equivalent of a clinical trial protocol: it proves your methodology was planned, not reverse-engineered.
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Emergency Response Team that Turns Audit Failures into Successful Resubmissions
Post-Audit Remediation is an urgent response service to address Clinical Evaluation deficiencies identified during a Notified Body audit or regulatory review. We diagnose the root cause of findings, develop corrective actions within 48 hours of engagement, rewrite or supplement documentation, and prepare you for re-submission or follow-up audit - with focus on preventing recurrence, not just papering over the immediate problem.
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Pre-Submission Audit That Identifies and Prioritises Clinical Evidence Weaknesses
A Clinical Evaluation GAP Analysis is a systematic pre-submission audit of your clinical evidence and documentation. We compare what you have (existing data, literature, technical files) against what MDR Annex XIV requires, identify missing or weak elements across seven critical dimensions, and provide a prioritised action plan to close gaps before you face a Notified Body - so you avoid surprises, delays, and audit findings that could have been prevented.
Bring your CER/CEP status - get a realistic route to audit readiness.
SciMed’s services are for you if…
You’re likely a good fit for SciMed’s Clinical Evaluation Services if you recognise yourself here:
You're preparing for a Notified Body audit…
…and need certainty that your clinical evidence will withstand scrutiny.
You're regulatory team is stretched thin…
…and can’t dedicate the time require to produce publication-quality Clinical Evaluation Reports.
You've received audit findings on your CER…
…or clinical data and need expert remediation support.
You're a start-up founder…
…and need a clear, cost-effective pathway through MDR clinical requirements without derailing your timeline.
You value scientific rigour…
…and won’t settle for templated reports that regulators see through immediately.
You want lifecycle compliance support…
…not just a one-time deliverable.
If you're looking for someone to rubber-stamp existing documentation or promise "first-attempt approval," we're not the right fit. Our clients value honest assessment and evidence-based solutions over hollow guarantees.
Why SciMed for Clinical Evaluation?
Our Clinical Evaluation Reports don't just satisfy regulatory requirements - they demonstrate genuine scientific evaluation. We apply the same rigor to your device's evidence as we would to a peer-reviewed publication, because regulators can tell the difference between thorough analysis and compliance theatre.
SciMed deliver Excellence Beyond Deliverables
Our Approach:
We find gaps before auditors do.
Every analysis includes proactive gap identification and remediation planning.
We explain the "why," not just the "what."
You'll understand the regulatory logic behind our recommendations, enabling better internal decision-making.
We act as your extended team.
We integrate with your existing staff, providing specialized expertise without requiring you to build in-house capability.
We prioritise scientific integrity.
We tell you the truth about your evidence position, even when it's uncomfortable. No hollow guarantees, no overselling.
Our mission is to provide regulatory support that combines rigorous science, flawless execution, and professional client service. When you work with us, you get polished documentation backed by evidence, organised systems that make compliance manageable, and a partner who represents your best interests with integrity.
Proof: Clinical Evaluation Case Studies
Free Resources: See the Latest Clinical Evaluation Resources from SciMed’s MedTech Horizon
We believe in helping you understand Clinical Evaluation requirements, even if you're not ready to engage us yet. These resources address the most common questions we hear:
Ready to Eliminate Compliance Blind Spots?
Book a Clinical Evaluation Consultation
We'll review your current clinical evidence position, identify any gaps, and outline a clear path to audit-ready documentation. No obligation, no sales pressure - just an honest assessment from experts who do this work every day.
For MedTech start-ups, clinical evaluation under the EU MDR is no longer a box-ticking exercise - it’s a strategic part of product development. By planning early, leveraging existing evidence, and embedding regulatory thinking from day one, companies can turn compliance into a competitive advantage and a pathway to credible market entry.