A guide to worst-case testing in MedTech
💥 A Meteorite Strikes and the Sky Falls on Us - The Art and Science of Defining Worst-Case Tests in Medical Technology. We believe that...
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MedTech Blog
Simon Föger
- Jul 27
- 5 min
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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Simon Föger
- May 30
- 2 min
Equipment Maintenance Plans in MedTech – 5 Reasons Why You Should Avoid DIY Maintenance Plans
Maintenance Plans in MedTech – 5 Reasons Why You Should Avoid "Do-It-Yourself" Maintenance Plans
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Simon Föger
- Apr 20
- 4 min
The 5 Most Common Calibration Errors You Should Avoid in MedTech
Calibration – The 5 Most Common Calibration Pitfalls You Should Avoid in MedTech
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Simon Föger
- Mar 23
- 2 min
Why Your Suppliers Do Not Need an ISO 13485 QMS Certification
Do your supplier need an ISO 13485 certificate?
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Simon Föger
- Mar 9
- 5 min
6 Reasons Why Your Technical Understanding is Essential for Process Validation in MedTech
Process Validation – 6 Reasons Why You Must Have a Good Technical Understanding to Validate Your Processes
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Simon Föger
- Oct 20, 2022
- 2 min
Attribute Agreement Analysis (Go/No Go Gage or Pass/Fail Test Systems)
In this blog post we discuss the validation approach of a Pass/Fail Test System aka Attribute Agreement Analysis or Go/No Go Gage. An...
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Simon Föger
- Oct 6, 2022
- 3 min
Destructive Test Methods: Gage Reproducibility Study (TMV of Continuous Destructive Measurements)
In the previous blog post about Gage R&R (with Minitab) aka Test Method Validation for continuous non-destructive measurements, we...
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Simon Föger
- Sep 28, 2022
- 4 min
Conducting a Gage R&R Study with Minitab (Explained with a Practical Example)
In the previous blog post about Test Method Validation, we already discussed different types of Test Method Validations, depending on the...
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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
- 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
- Nov 2, 2021
- 3 min
Installation Qualification (IQ)
Installation Qualification (IQ) in MedTech – Ticking off as necessary evil or to build a strong foundation?
286 views0 comments
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 20, 2021
- 4 min
Process Validation Sample Size – Cpk of 1.33 is not enough!
Process Validation Sample Size – Cpk of 1,33 is not enough!
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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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