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15/04/2026

When Literature Is Not Enough
🔍Recognizing data gaps is a strength — not a weakness.

A comprehensive literature search is essential for Clinical Evaluation.
But sometimes, even a well-executed review reveals one uncomfortable truth:
The available evidence is insufficient.

Typical Situations Where Literature Falls Short
✔️ Small sample sizes
✔️ Non-comparable patient populations
✔️ Conflicting outcome results
✔️ Limited data for specific subgroups or indications

What Happens Next?
Literature gaps should directly inform:
✔️ PMCF planning
✔️ Claim adjustments
✔️ Potential need for clinical investigation

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

13/04/2026

Linking Literature to Clinical Claims

If a claim (or endpoint) cannot be mapped to evidence, it cannot be defended.

What Strong Traceability Looks Like:
✔️ A defined list of clinical claims
✔️ Quantified/measurable outcome parameters
✔️ Identified supporting studies
✔️ Results

This creates a transparent mapping:
Claim/Endpoint → measurable Parameter → Study → Result → CER Conclusion

Without this logic chain, conclusions appear generic.

Common Weaknesses
🚩 Claims formulated broadly, evidence narrow
🚩 Study population does not match intended purpose
🚩 Favorable results highlighted, conflicting data minimized
🚩 No clear cross-reference between claims and studies

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

10/04/2026

Data Is Not Evidence: Critical Appraisal

What Critical Appraisal Actually Means
It requires structured evaluation of:
✔️ Study design (prospective, randomized, observational?)
✔️ Sample size and statistical robustness
✔️ Follow-up duration
✔️ Endpoint relevance
✔️ Population alignment with intended purpose
✔️ Risk of bias

Not all studies carry the same evidentiary weight.

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

08/04/2026

The Screening Process: Where Bias Creeps In

Your literature search is only as objective as your screening.

The Typical Screening Steps
A structured screening process usually includes:
1️⃣ Title and abstract screening
2️⃣ Full-text assessment
3️⃣ Final inclusion decision
At each step, studies are excluded.

Where Problems Often Arise
🚩 Decisions based on interpretation instead of predefined criteria
🚩 Inconsistent application of inclusion/exclusion rules
🚩 Missing documentation of exclusion reasons
🚩 Selective inclusion of favorable outcomes

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

07/04/2026

Inclusion & Exclusion Criteria Done Right

Why They Matter
These criteria determine:
✔️ Which studies are considered relevant
✔️ Which study designs are admissible
✔️ Which publication types are excluded

If criteria are vague, decisions become subjective.
Subjectivity leads to bias.
Bias leads to review questions.

💡Exclusion criteria should primarily focus on methodological and structural parameters, not on subjective relevance judgments.
They typically address:
✔️ Alignment with intended purpose
✔️ Relevant indication
✔️ Study Design
✔️ Data Completeness & Transparency

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

03/04/2026

What Makes a Literature Search Reproducible?
Reproducibility is not created by good intentions.
It is created by structure.
A defensible literature review is therefore built on three distinct documents:
1️⃣ Literature Search Plan
(Before you start searching)
The Plan defines the strategy.
It should include:
✔️ Sources of publications
✔️Search terms
✔️ Defined filter
✔️ Appraisal criteria and process for identified publications
✔️ Process for analysis of relevant publications

2️⃣ Literature Search Protocol
(What you actually did)
The Protocol documents ex*****on.
It includes:
✔️ Individual search queries and results per search query
✔️ Deviations from the Search & Review Plan
✔️ Summary of conducted searches and search results

3️⃣ Literature Search Report
(How results were handled and evaluated)
The Report explains:
✔️ Summary of objective search ex*****on and results
✔️ Conducted search and selection procedure for identification by other means
✔️ Appraisal of identified publications
✔️ Analysis of relevant publications

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

01/04/2026

State of the Art (SotA) vs Device-Specific Literature

One of the most common mistakes:
Mixing State of the Art (SotA) literature with device-specific evidence.

They serve different purposes.

1️⃣ State of the Art (SotA)
SoTA answers the question:
What is currently accepted medical and technical practice?
It defines:
✔️ Available treatment options
✔️ Established technologies
✔️ Typical complication rates
✔️ Expected clinical outcomes
✔️ Measurable parameters for similar devices or applications
SotA creates the reference framework.
Without it, you cannot objectively assess safety, performance, or benefit–risk.

2️⃣ Device-Specific Literature
Device-specific evidence answers a different question:
How does your device perform within that framework?
It supports:
✔️ Clinical claims/endpoints
✔️ Safety data (new risks, side effects,...)
✔️ Comparative positioning regarding SotA
This layer demonstrates whether your device meets or exceeds the benchmark defined by SotA.

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

30/03/2026

🔎 Search Strategy Before Search Ex*****on
Why planning your literature search matters more than the search itself
One of the most common weaknesses in clinical evaluations is not the lack of literature —
it’s the lack of a clear search strategy before the search begins.

Under the MDR, your literature review must be systematic and reproducible.
That means you cannot “search and see what comes up.”
You must define your strategy first.

📋 What should be defined before starting the search?
1️⃣ The objective of the search
2️⃣ Defined databases
3️⃣ Predefined inclusion & exclusion criteria
4️⃣ Search strings

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

27/03/2026

📚 Why Literature Search Is the Backbone of Clinical Evaluation

Under the MDR, clinical evaluation must be systematic, transparent, and evidence-based (Article 61 & Annex XIV).
And at the core of that requirement lies one critical activity:
👉 A robust, reproducible literature search.
Without a structured literature review, your CER risks becoming:
-selective instead of systematic
-descriptive instead of analytical
-vulnerable instead of defensible

Under the MDR, literature is not a background chapter.
It forms the foundation for:
✔️ State of the Art
✔️ Clinical claims
✔️ Benefit–risk justification
✔️ Identification of data gaps

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

25/03/2026

Checklist Add-On: Are You Prepared for the MDCG 2020-13 Review Structure?

The MDCG 2020-13 provides the official template used by notified bodies to assess Clinical Evaluation documentation under the MDR.
In other words:
It shows how your CER will be examined.
Why This Matters
The template structures the assessment into key review blocks such as:
✔️ Intended purpose and claims/endpoints
✔️ Clinically relevant risks
✔️ Similar devices
✔️ State of the art
✔️ Data identification and appraisal
✔️ Equivalence justification
✔️ PMS and PMCF integration
✔️ Benefit–risk determination
If your CER does not clearly address these sections, reviewers will struggle — and that usually results in questions.
Practical Tip
💡Use the MDCG template as an internal pre-audit checklist

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

23/03/2026

Final Checklist: Is Your Clinical Evaluation Audit-Ready?
After walking through the key elements of Clinical Evaluation under the MDR, one final question remains:
Quick Recap – The Core Checklist
An audit-ready Clinical Evaluation should demonstrate:
✔️ A robust Clinical Evaluation Plan (CEP)
✔️ A clearly defined intended purpose
✔️ A justified evidence route (own clinical data, equivalence data, or performance data)
✔️ A structured and reproducible systematic literature review
✔️ A well-defined State of the Art with measurable parameters
✔️ Clearly defined and traceable clinical claims/endpoints
✔️ A structured benefit–risk assessment
✔️ Full integration of PMS and PMCF
✔️ Regular and trigger-based updates
✔️ Consistency across CER, IFU, risk management, and marketing documentation

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

20/03/2026

Checklist Focus: Is Your Clinical Evaluation Internally Consistent?
Clinical Evaluation does not exist in isolation.
It sits at the center of your technical documentation — and must align with multiple other regulatory documents.
A robust checklist should verify consistency between:
✔️ Intended purpose – identical wording and scope across all documents
✔️ Risk management file – hazards, residual risks, and clinical data aligned
✔️ IFU – indications, contraindications, warnings supported by clinical evidence
✔️ Marketing claims – no statement without clinically proven
✔️ PMS documentation – post-market findings reflected in the CER
Why this matters
Inconsistencies are among the most frequent audit findings.
Typical examples:
🚩 A broader indication in marketing than in the CER and not proven by clinical data
🚩 Clinically relevant risks listed in the RMF but not clinically discussed
🚩 PMS trends not reflected in benefit–risk updates

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

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