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MedTech Blog
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When More IS Better – Process Variation & Sample Sizes
Let's delve into the topic of process variation and the importance of adequate sample sizes.
Simon Föger
Jun 13, 20243 min read
125 views
0 comments
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...
Simon Föger
Mar 11, 20243 min read
400 views
0 comments
A Guide to Worst-Case Testing in MedTech
The Art and Science of Defining Worst-Case Tests in MedTech.
Simon Föger
Oct 30, 20233 min read
270 views
0 comments
Medical Device Audits: A Typical Day in the Shoes of an Auditor
Medical Device Quality Audits: A Day in the Shoes of an Auditor
Simon Föger
Jul 27, 20235 min read
78 views
0 comments
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
Simon Föger
May 30, 20232 min read
52 views
0 comments
The 5 Most Common Calibration Errors You Should Avoid in MedTech
Calibration Errors – The 5 Most Common Calibration Errors You Should Avoid in MedTech
Simon Föger
Apr 20, 20234 min read
258 views
0 comments
Why Your Suppliers Do Not Need an ISO 13485 QMS Certification
Do your supplier need an ISO 13485 certificate?
Simon Föger
Mar 23, 20232 min read
41 views
0 comments
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
Simon Föger
Mar 9, 20235 min read
35 views
0 comments
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.
Simon Föger
Oct 20, 20223 min read
547 views
0 comments
Destructive Test Methods: Gage Reproducibility Study (TMV of Continuous Destructive Measurements)
Destructive Test Methods: Learn how to approach a Gage Reproducibility study.
Simon Föger
Oct 6, 20223 min read
485 views
0 comments
Conducting a Gage R&R Study with Minitab (Explained with a Practical Example)
Learn how to conduct a Gage R&R Study with Minitab.
Simon Föger
Sep 28, 20224 min read
1,205 views
0 comments
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.
Simon Föger
Sep 8, 20225 min read
7,146 views
0 comments
Performance Qualification (PQ) – Run 3 Batches And Ready, Right?
Performance Qualification (PQ) – Run 3 batches and ready, right?
Simon Föger
Jul 19, 20222 min read
368 views
0 comments
Operational Qualification (OQ)
Operational Qualification (OQ) – The fun part of medical device Process Validation!
Simon Föger
Jan 11, 20225 min read
2,133 views
0 comments
Installation Qualification (IQ)
Installation Qualification (IQ) in MedTech – Ticking off as necessary evil or to build a strong foundation?
Simon Föger
Nov 2, 20213 min read
743 views
0 comments
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.
Simon Föger
Oct 3, 20215 min read
701 views
0 comments
Process Validation Sample Size – Cpk of 1.33 is not enough!
Process Validation Sample Size – Cpk of 1.33 is not enough!
Simon Föger
Sep 20, 20215 min read
1,813 views
0 comments
Statistical Tolerance Intervals – Explained simply and practically based on ISO 16269-6
Statistical Tolerance Interval in MedTech – Explained based on ISO 16269-6
Simon Föger
Sep 7, 20215 min read
1,364 views
0 comments
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