The 5 Most Common Calibration Pitfalls You Should Avoid in MedTech
A quick search of the FDA warning letter database shows more than a dozen entries around 21 CFR 820.72. Calibration is a well-understood...
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All About MedTech Blog
Simon Föger
- Mar 23
- 2 min
Why Your Suppliers Do Not Need an ISO 13485 Certification
ISO 13485 is an internationally recognized standard for quality management systems specifically designed for the medical device industry....
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Simon Föger
- Mar 9
- 4 min
6 Reasons Why Your Technical Understanding is Essential to Validate Processes in MedTech
Process validation ensures that manufacturing processes reliably produce products that meet predetermined specifications and quality...
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Simon Föger
- Oct 20, 2022
- 3 min
Test Method Validation of Pass/Fail Test Systems
... no matter whether they are destructive or not. In this last blog post about Test Method Validation, we discuss the validation...
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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...
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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?
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
- 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...
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Simon Föger
- Nov 2, 2021
- 3 min
Installation Qualification (IQ)
Ticking-off as a necessary evil or to build a strong foundation? Do you think Installation Qualification (IQ) is the least important part...
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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 20, 2021
- 4 min
Process Validation Sample Size – 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...
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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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