The 4 Most Common Mistakes in the Risk Acceptance Matrix
In the past, medical device manufacturers have used risk acceptance matrices with large green areas where the occurrence of damage was...
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All About MedTech Blog
Sophia Hurmann
- Feb 14
- 4 min
Vietnam – a Sourcing Country for the Medical Device Industry?
The strategic decision of where to source materials is becoming increasingly difficult. The trade war between the U.S. and China, the...
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Bernhard Lindner
- Jan 19
- 2 min
Risk acceptance threshold: How many deaths are we willing to accept?
There are increasing reports from the field that insufficiently justified risk acceptance limits have led to problems with product...
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Bernhard Lindner
- Nov 3, 2022
- 2 min
FMEA is not risk analysis!
Over the past few decades, medical device manufacturers have used FMEA (Failure Mode and Effects Analysis) as a risk analysis tool....
32 views0 comments
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...
125 views0 comments
Simon Föger
- Jul 19, 2022
- 2 min
Performance Qualification (PQ) – Run 3 batches and ready, right?
Great, you finished the Operational Qualification (OQ), found your process window, and now must show the consistency of your process. The...
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Simon Föger
- Apr 1, 2022
- 6 min
Cultural differences… And how to not let them become an issue by using Erin Meyer's culture map
When working with people from different cultural backgrounds, we sometimes think we can work together just like we do with people from...
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Simon Föger
- Jan 11, 2022
- 4 min
Operational Qualification (OQ)
The fun part of medical device process validation! Great, you finished the installation qualification (IQ) and now want to start with the...
365 views0 comments
Simon Föger
- Oct 3, 2021
- 4 min
Medical Device Manufacturing: Are you familiar with Process Validation?
Yeah, sure, it's IQ, OQ, and PQ! What's really behind these acronyms that everyone believes to know! Does your customer suddenly want you...
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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 intervals are frequently used during process validation and design verification, maybe because the approach is...
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