When More IS Better – Process Variation & Sample Sizes
Let's delve into the topic of process variation and the importance of adequate sample sizes.
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MedTech Blog
Simon Föger
Mar 113 min read
How The EU MDR Changed The Landscape of Process Validation
Spoiler: The EU MDR did not invent Process Validation; nor did it introduce the requirement for Test Method Validation. How the EU MDR...
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Simon Föger
Oct 30, 20232 min read
A Guide to Worst-Case Testing in MedTech
The Art and Science of Defining Worst-Case Tests in MedTech.
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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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Simon Föger
May 30, 20232 min read
Equipment Maintenance Plans in MedTech – 5 Reasons Why You Should Avoid DIY Maintenance Plans
Equipment Maintenance Plans in MedTech – 5 Reasons Why You Should Avoid "Do-It-Yourself" Maintenance Plans
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Simon Föger
Apr 20, 20234 min read
The 5 Most Common Calibration Errors You Should Avoid in MedTech
Calibration Errors – The 5 Most Common Calibration Errors You Should Avoid in MedTech
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Simon Föger
Mar 23, 20232 min read
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, 20235 min read
6 Reasons Why Your Technical Understanding is Essential for Process Validation in MedTech
Technical Understanding in MedTech – 6 Reasons Why You Must Have a Good Technical Understanding to Validate Your Processes
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Simon Föger
Oct 20, 20223 min read
Attribute Agreement Analysis (Go/No Go Gage or Pass/Fail Test Systems)
Attribute Agreement Analysis, or also called Go/No Go Gage: Learn all about the validation approach of a pass/fail test system.
371 views0 comments
Simon Föger
Oct 6, 20223 min read
Destructive Test Methods: Gage Reproducibility Study (TMV of Continuous Destructive Measurements)
Destructive Test Methods: Learn how to approach a Gage Reproducibility study.
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Simon Föger
Sep 28, 20224 min read
Conducting a Gage R&R Study with Minitab (Explained with a Practical Example)
Learn how to conduct a Gage R&R Study with Minitab.
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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
Jan 11, 20224 min read
Operational Qualification (OQ)
Operational Qualification (OQ) – The fun part of medical device Process Validation!
1,762 views0 comments
Simon Föger
Nov 2, 20213 min read
Installation Qualification (IQ)
Installation Qualification (IQ) in MedTech – Ticking off as necessary evil or to build a strong foundation?
615 views0 comments
Simon Föger
Oct 3, 20214 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 20, 20215 min read
Process Validation Sample Size – Cpk of 1.33 is not enough!
Process Validation Sample Size – Cpk of 1.33 is not enough!
1,421 views0 comments
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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