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MedTech Blog
Dive into our comprehensive blog posts on Quality, Risk, and Supplier Management and learn from our best-practices. Stay informed with the latest updates and expert tips by subscribing to our newsletter – ensuring you are among the first to receive new content.
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
489 views
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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
1,222 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
7,245 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
374 views
0 comments
Cultural Differences in International Business… And How To Not Let Them Become an Issue
Cultural Differences… And How To Not Let Them Become an Issue by Using Erin Meyer's Culture Map
Simon Föger
Apr 1, 20226 min read
475 views
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Operational Qualification (OQ)
Operational Qualification (OQ) – The fun part of medical device Process Validation!
Simon Föger
Jan 11, 20225 min read
2,139 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
744 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
703 views
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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
1,829 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
1,382 views
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