Medical Device Audits: A Typical Day in the Shoes of an Auditor
Have you ever wondered what a medical device audit is like? And above all, what does it look like from the auditor's point of view? In...
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MedTech Blog
Bernhard Lindner
- Feb 23
- 2 min
The 4 Most Common Mistakes in the Risk Acceptance Matrix
The 4 Most Common Mistakes in the Risk Acceptance Matrix & How To Avoid Them!
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Sophia Hurmann
- Feb 14
- 4 min
Vietnam – a Sourcing Country for the Medical Device Industry?
Sourcing Decisions – Vietnam as a sourcing country for medical device manufacturers?
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Bernhard Lindner
- Jan 19
- 2 min
Risk Management for Medical Devices: How Many Deaths Are We Willing To Accept?
There is more and more feedback from the field that there are problems with product approvals – due to insufficiently justified risk...
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Bernhard Lindner
- Nov 3, 2022
- 2 min
FMEA is Not Risk Analysis!
FMEA is not suitable as a tool for risk analysis.
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Simon Föger
- Sep 8, 2022
- 4 min
Test Method Validation (TMV) in Medical Device Manufacturing
You may be thinking, "OMG, what more do we need to validate? Is this still not enough?" Well, no, it isn't. Fortunately, we really need...
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Simon Föger
- Jul 19, 2022
- 2 min
Performance Qualification (PQ) – Run 3 Batches And Ready, Right?
Performance Qualification (PQ) – Run 3 batches and ready, right?
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Simon Föger
- Apr 1, 2022
- 6 min
Cultural Differences in International Business… And How To Not Let Them Become an Issue
Cultural Differences… And How To Not Let Them Become an Issue by Using Erin Meyer's Culture Map
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Simon Föger
- Jan 11, 2022
- 4 min
Operational Qualification (OQ)
Operational Qualification (OQ) – The fun part of medical device Process Validation!
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Simon Föger
- Oct 3, 2021
- 4 min
Process Validation in Medical Device Manufacturing: How Familiar Are You With IQ, OQ, and PQ?
IQ, OQ, PQ – What's really behind these acronyms that everyone believes to know – Process Validation in Medical Device Manufacturing.
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Simon Föger
- Sep 7, 2021
- 5 min
Statistical Tolerance Intervals – Explained simply and practically based on ISO 16269-6
Statistical Tolerance Interval in MedTech – Explained based on ISO 16269-6
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