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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M.F. Siddiqui & S. Hurmann
- Dec 29, 2022
- 5 min
3 strategies to make your supply chain more resilient as a MedTech-SME in 2023
The pandemic has exposed supply chain vulnerabilities and forced us to revise old strategies. What once worked now no longer does....
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Bernhard Lindner
- Dec 1, 2022
- 2 min
The underestimated value of "clinical benefit" in medical device risk management
In the MDR, the benefit-risk ratio is given a much higher priority than was the case in the MDD. The frequency with which the term...
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Bernhard Lindner
- Nov 17, 2022
- 2 min
How to minimize risks "as far as possible"!
How to minimize risks "as far as possible"! The MDR demands in Annex I that medical device manufacturers must minimize risks "as far as...
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Bernhard Lindner
- Nov 3, 2022
- 2 min
FMEA is not risk analysis!
Author: Bernhard Lindner Over the past few decades, medical device manufacturers have used FMEA (Failure Mode and Effects Analysis)as a...
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Simon Föger
- Oct 20, 2022
- 2 min
Test Method Validation of Pass/Fail Test Systems
In this last blog post about test method validation, we discuss the validation approach of a pass/fail test system. A pass/fail test...
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Simon Föger
- Oct 6, 2022
- 3 min
Test Method Validation of Continuous Destructive Measurements
Also known as Gage Reproducibility study! In the previous blog post about test method validation for continuous non-destructive...
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Simon Föger
- Sep 28, 2022
- 4 min
Test Method Validation of Continuous Non-Destructive Measurements
Also known as Gage Repeatability and Reproducibility! In the previous blog post about test method validation, we already discussed...
14 views0 comments
Simon Föger
- Sep 8, 2022
- 4 min
Test Method Validation
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 - Run 3 batches and ready, right?
Great, you finished the OQ, found your process window, and now must show the consistency of your process. The performance qualification...
46 views0 comments
Simon Föger
- Apr 1, 2022
- 6 min
Cultural differences… And how to not let them become an issue!
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
The fun part of process validation! Great, you finished the IQ and now want to start with the fun part? The operational qualification...
159 views0 comments
Simon Föger
- Nov 2, 2021
- 3 min
Installation Qualification
Ticking-off as a necessary evil or to build a strong foundation? Do you think IQ is the least important part of process validation? Do...
59 views0 comments
Simon Föger
- Oct 3, 2021
- 4 min
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...
156 views0 comments
Simon Föger
- Sep 20, 2021
- 4 min
Cpk of 1,33 is not enough!
A deep dive into sample sizes for process validation Are you questioning why a Cpk of 1,33 should not be enough, although it means only...
183 views0 comments
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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