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.
200 views0 comments
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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Sophia Hurmann
Apr 11, 20233 min read
Supplier Management in MedTech – Top 7 Benefits of Working with a Trading Partner
MedTech Supplier Management: 7 Benefits of Working with a Trading Partner
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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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Bernhard Lindner
Feb 23, 20232 min read
The 4 Most Common Mistakes in the Risk Acceptance Matrix
The 4 Most Common Mistakes in the Risk Acceptance Matrix & How To Avoid Them!
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Sophia Hurmann
Feb 14, 20234 min read
Vietnam – a Sourcing Country for the Medical Device Industry?
Sourcing Decisions – How important is Vietnam as a sourcing country for medical device manufacturers?
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Bernhard Lindner
Jan 19, 20232 min read
Risk Management for Medical Devices: How Many Deaths Are We Willing To Accept?
There is more and more feedback from the field that there are problems with product approvals – due to insufficiently justified risk...
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Sophia Hurmann
Dec 29, 20225 min read
3 Strategies to Make Your Supply Chain More Resilient as a Medical Device SME in 2023
The pandemic has exposed supply chain vulnerabilities and forced us to revise old strategies. What once worked now no longer does....
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Bernhard Lindner
Dec 1, 20222 min read
The Underestimated Value of "Clinical Benefit" in Medical Device Risk Management
The Underestimated Value of "Clinical Benefit" in Medical Device Risk Management
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Bernhard Lindner
Nov 17, 20222 min read
How To Minimize Risks "as far as possible" in MedTech
How to minimize risks "as far as possible" when producing medical devices.
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Bernhard Lindner
Nov 3, 20222 min read
FMEA is Not Risk Analysis!
FMEA is not suitable as a tool for risk analysis.
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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.
747 views0 comments
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.
4,745 views0 comments
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