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Als CRO unterstützt das medXteam Sie während des gesamten Prozesses der Generierung und Bewertung klinischer Daten und bei der Zulassung und Marktbeobachtung von Medizinprodukten

16/07/2025

💡Did you know?
The new MDCG 2025-5 provides detailed Q&A guidance on performance studies of in vitro diagnostic medical devices (IVDs) under the IVDR (EU) 2017/746.
🎯 Why this matters:
This document clarifies which studies require notification or application, and under what conditions. It also explains how to handle left-over samples, interventional studies, and companion diagnostics.
🧩 Key insights from the guidance:
-Not all performance studies require submission to a competent authority – but many do, based on factors like invasiveness or use of companion diagnostics.
-Clarifies what counts as a performance study
-Offers a decision tree to determine regulatory pathways
-Covers substantial modifications, ethical review, and sponsor responsibilities
📘 Full document:https://health.ec.europa.eu/document/download/f22f559b-dee5-43b4-9595-3ccdcca9f7ad_en?filename=mdcg_2025-5_en.pdf

14/07/2025

📂 A Clean Risk Management File – Step by Step
🧹 Messy files lead to messy audits.
A clear, structured risk management file isn’t just nice to have — it's a regulatory must-have.
If you're working under ISO 14971 and the EU MDR, here's what a robust and inspection-ready risk management file should include:
🔹 1️⃣ Risk Management Plan
→ Scope, methodology, roles, criteria for acceptability
🔹 2️⃣ Preliminary Hazard Analysis (PHA)
→ Based on intended use, misuse, environment, and device design
🔹 3️⃣ Risk Analysis & Evaluation
→ Choose your method: FMEA, Fault Tree, PHA – and apply consistently
🔹 4️⃣ Risk Control Measures
→ Think in levels: inherent design changes > protective features > user training & IFU > verification & validation tests
🔹 5️⃣ Residual Risk Evaluation
→ Link to benefit-risk assessment and clinical justification
🔹 6️⃣ Production & Post-Market Risks
→ Incorporate PMS, complaints, CAPAs, PMCF into the overall picture
🔹 7️⃣ Risk Management Report
→ Provide a summary, verification steps, and traceability to your Clinical Evaluation Report (CER)
📁 Pro Tip: Keep your file modular, version-controlled, and easily cross-referenced.

09/07/2025

Did you know?
The new MDCG 2025-4 guidance brings clarity on how medical device software (MDSW) apps should be safely made available via online platforms.
🚨 This is the first MDCG guidance that connects the Medical Device Regulation (MDR/IVDR) with the Digital Services Act (DSA) – a game-changer for anyone distributing apps in the EU.
🔍 Key takeaways:
✅App platforms (like Apple, Google, or medical-specific stores) may be considered distributors, importers, or intermediary service providers, depending on their role.
✅If platforms distribute their own MDSW, they are economic operators under MDR/IVDR — and must comply with Articles 13 & 14.
✅If acting only as intermediaries (hosting third-party apps), DSA rules apply: liability exemption, illegal content takedowns, and transparency obligations.
✅Clear information must be provided on the platform: UDI, manufacturer info, labeling, warnings, eIFU links — directly visible to users and patients.
✅Platforms must ensure distinction between medical, wellness, and lifestyle apps for proper categorization.
📘 Read the full guidance here: https://health.ec.europa.eu/latest-updates/mdcg-2025-4-guidance-safe-making-available-medical-device-software-mdsw-apps-online-platforms-june-2025-06-16_en

07/07/2025

💡 Risk Management 101: Key terms you should really know
If you’re working on your technical documentation — understanding these terms is essential.
Here’s a glossary of 6 fundamental risk management terms:
🔍 1. Residual risk
The risk that remains after all control measures have been applied.
👉 Must be justified — especially in benefit-risk assessments.
⚖️ 2. Benefit-risk ratio
Does the clinical benefit clearly outweigh the remaining risks?
👉 Evaluated in the clinical evaluation.
🛡️ 3. Risk control measure
Design, protective features, or information to reduce risks.
👉 Apply the hierarchy: Design > Protection > Instructions.
🎯 4. Risk acceptability criteria
Defined thresholds to determine if a risk is acceptable.
👉 Typically laid out in your risk management plan.
📊 5. Severity vs. probability
Risk = Severity × Probability.
👉 Two key dimensions used in risk matrices.
⚠️ 6. Hazardous situation vs. harm
Hazardous Situation = A condition that could lead to harm
Harm = Actual injury or adverse effect

02/07/2025

📢 Did you know?
A new regulation — Implementing Regulation (EU) 2025/1234, adopted on 25 June 2025, significantly expands the scope of electronic instructions for use (eIFU) for medical devices in the EU.
🆕 What’s new?
✅eIFUs are now allowed for all medical devices and their accessories intended for professional use, including legacy devices under MDR Article 120.
✅The scope also includes Annex XVI products (non-medical purpose), as long as they’re for professional users.
✅If a device may reasonably be used by lay persons, a paper IFU must still be provided.
✅Manufacturers must provide the URL for eIFUs in the UDI database once EUDAMED registration becomes mandatory.
✅Several clarifications and simplifications reduce redundancy and legal ambiguity from the 2021 regulation.
🔗 Read the full text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202501234

30/06/2025

🎙️ New Podcast Episode Is Live!

"Claims vs. Evidence: turning assumptions into solid proof"
In this episode, we dive into one of the most misunderstood topics in clinical evaluation: making strong, evidence-based claims.
🚫 “Well, we’ve always said that…”
What used to be accepted as a valid claim in clinical evaluations just a few years ago often doesn’t hold up today. The MDR has raised the bar.

Here’s what you’ll learn:
✅ Why vague or generic claims won’t pass scrutiny anymore
✅ Which claims were commonly used in the past — and why they now fail
✅ How to develop robust, measurable claims for clinical safety, clinical performance, and the clinical benefit
✅ What types of data and parameters actually support those claims in a compliant, convincing way
🎯 Whether you're updating your clinical evaluation or working on a new submission, this episode is a must-listen for everyone in MedTech and regulatory affairs.
🎧 Listen now:
-Apple Podcast: https://podcasts.apple.com/de/podcast/medxteam-kompakt/id1710726795?i=1000715125301
-Spotify: https://open.spotify.com/episode/40ceoGw5srq9FXM7z1wDFA?si=s_2ZuKnGTsG9nqQJcfPOhw
📌 Follow us for more real-world insights into clinical and regulatory strategy.

27/06/2025

🔄 Managing the Interface: Risk Management & Clinical Evaluation

Risk management and clinical evaluation are often treated as separate tracks.�But under the MDR, they are deeply connected — and their alignment is key for compliance.
Here’s how to manage the interface effectively 👇

✅ 1. Safety Data from PMS → CER
PMS and vigilance data (e.g. incident reports, trend analysis) feed directly into the safety profile of the device in the Clinical Evaluation Report (CER).

✅ 2. Residual Risks ↔ Clinical Acceptability
Not all risks can be eliminated. The residual risks identified in the Riskmanagement must be evaluated in the CER as:
* Clinically acceptable?
* Supported by benefit-risk evidence?
👉 This closes the loop between technical documentation and clinical justification.

✅ 3. State of the Art (SOTA) ↔ Hazard Identification
The Clinical Evaluation defines the state of the art, including comparable devices and standards.�These inform:
* New hazard identification
* Updated risk control strategies

💡 Pro Tip: Align your update cycles! Whenever you revise the CER or PMS, review your risk documentation too.

23/06/2025

⚙️ Risk Control Measures – How to Effectively Minimize Hazards

Identifying a risk is just the beginning.�The real question is: What are you doing about it – and how effective is it?
Under ISO 14971 and EU MDR, you must do more than document hazards.�
You need to show that your risk control measures are:
✅ appropriate
�✅ implemented�
✅ and proven to be effective

🧰 Three Levels of Risk Control (ISO 14971)

1️⃣ Inherent safety by design�
– Change materials, remove functions, reduce energy�
→ Most effective and preferred
2️⃣ Protective measures
�– Shields, alarms, auto-shutdowns�
→ Helps mitigate harm if hazard occurs
3️⃣ Information for safety�
– Warnings in IFU, training, labels�
→ Least effective

📌 Good Practice Tip:�For each control, document:�
✔️ What was implemented�
✔️ How it reduces risk�
✔️ How you verified its effectiveness

💡 Bonus: Link your risk controls to usability validation!

20/06/2025

👥 Risk Management & Usability – A Critical Connection

It’s one of the most overlooked relationships in regulatory documentation:�
👉 ISO 14971 and IEC 62366 are not separate silos – they are two sides of the same risk strategy.
Here’s why usability engineering is essential to risk management:

✅ Use errors = Use-related hazards
Design issues, unclear displays, or cognitive overload can all cause harm – even without technical failure.
✅ Usability testing = Risk control verification
Summative evaluations show whether your interface mitigates real-world risks effectively.
✅ User interface design = Risk mitigation strategy
Instructions, alarms, screen layout – they’re not “nice to have”. They’re documented controls in your Risk management file.
✅ Residual risks → must be explained in the IFU
If a user risk can’t be eliminated through design, it must be clearly communicated – and usability-tested.

18/06/2025

📄 Risk Management under MDR: Which documents are required?

Risk Management is not just an analysis – it’s a documented process from start to finish.
And under MDR + ISO 14971, a complete and traceable set of documents is expected.
So what do you need? ✔️

✅ 1. Risk Management Plan
Defines your risk strategy, criteria, responsibilities, and methodology.
✅ 2. Preliminary Hazard Analysis (PHA)
Initial identification of potential hazards – often done early in design or based on legacy data.
✅ 3. Risk Analysis (e.g. FMEA)
Detailed assessment of hazards, causes, effects, and risk levels – including risk control measures and their effectiveness.
✅ 4. Risk Management Report
Final document summarizing the entire process, confirming risk acceptability, and linking to other documents (CER, IFU, PMS).

📌 A complete Risk Management File is essential for CE marking – and will be reviewed in detail during audits.

16/06/2025

📊 TD for Class I vs. Class III Devices: What’s the Difference?

Under the MDR, all medical devices require Technical Documentation (TD) – but not all TDs are created equal.
The higher the risk class, the deeper the evidence and the stricter the oversight.

Here’s a quick comparison between Class I and Class III devices:
✅Notified Body Involvement:
⚙️ Class I: ❌ Not required (self-declaration)
🧠 Class III: ✅ Full review & conformity assessment
✅PSUR:
⚙️ Class I: ❌ Not required (but the PMS Report!)
🧠 Class III: ✅ Required annually
✅Update Frequency:
⚙️ Class I: As needed based on risk (PMS, CER: ~every 2 to 5 years)
🧠 Class III: At least once per year (PSUR, CER, RM updates mandatory)

📌 Takeaway:�Don’t underestimate Class I – the MDR still expects traceability, justification, and proper PMS. Even if there is no Notified Body there are inspections by authorities also reviewing your TD!�But for Class III, your TD must be audit-proof, data-rich, and fully interconnected.
💡 Make sure your documentation is not just complete – but risk-class appropriate.

13/06/2025

🔍 TD & Risk Management: 5 Critical Interfaces You Shouldn’t Overlook
Your Risk Management File is not just a standalone document – it’s deeply embedded in your Technical Documentation (TD) and connects to multiple disciplines.
Here are 5 critical interfaces you must manage proactively under the EU MDR:

1️⃣ Risk Management ↔ PMS�
PMS findings (e.g. complaints, trend reports) feed directly into the Risk Management File.�
New risks? ➜ Risk analysis and control measures must be updated.

2️⃣ Risk Management ↔ Clinical Evaluation (CER)
�All clinical risks must be reflected in the Risk Management File.�
Residual risks must be justified using PMS or clinical evidence – and the benefit-risk ratio must align.

3️⃣ Risk Management ↔ Usability�
Use errors = use-related hazards.�
Usability tests verify risk control effectiveness. IEC 62366 and ISO 14971 go hand in hand.

4️⃣ Risk Management ↔ IFU / Labeling
�Residual risks that cannot be eliminated must be communicated.�
Warnings, precautions, contraindications → directly derived from the Risk Management File.

5️⃣ Risk Management ↔ Preclinical Testing (e.g. Biocompatibility)�
Risks related to materials, leachables, or degradation must be supported by test data.�
Test selection is risk-based – and test outcomes must feed back into the Risk Management File.

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