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MedTech Blog
Dive into our comprehensive blog posts on Quality, Risk, and Supplier Management and learn from our best-practices. Stay informed with the latest updates and expert tips by subscribing to our newsletter – ensuring you are among the first to receive new content.
Simon Föger
Jul 27, 20235 min read
Medical Device Audits: A Typical Day in the Shoes of an Auditor
Medical Device Quality Audits: A Day in the Shoes of an Auditor
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Bernhard Lindner
Feb 23, 20232 min read
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, 20234 min read
Sourcing in Vietnam: A Rising Opportunity for the Medical Device Industry?
Sourcing Decisions – How important is Vietnam as a sourcing country for medical device manufacturers?
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Bernhard Lindner
Jan 19, 20232 min read
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, 20222 min read
FMEA is Not Risk Analysis!
FMEA is not suitable as a tool for risk analysis.
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Simon Föger
Sep 8, 20225 min read
Test Method Validation (TMV) in Medical Device Manufacturing
Test Method Validation in Medical Device Manufacturing: Get a deep dive into the important topic of TMV.
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Simon Föger
Jul 19, 20222 min read
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, 20226 min read
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, 20225 min read
Operational Qualification (OQ)
Operational Qualification (OQ) – The fun part of medical device Process Validation!
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Simon Föger
Oct 3, 20215 min read
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, 20215 min read
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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