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
63 views0 comments
Sophia Hurmann
- Apr 11
- 3 min
Supplier Management in MedTech – Top 7 Benefits of Working with a Trading Partner
Are you a medical device manufacturer and source components for manufacturing your products abroad? Then you already know about the risks...
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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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Bernhard Lindner
- Feb 23
- 2 min
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
- 4 min
Vietnam – a Sourcing Country for the Medical Device Industry?
Sourcing Decisions – Vietnam as a sourcing country for medical device manufacturers?
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Bernhard Lindner
- Jan 19
- 2 min
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, 2022
- 5 min
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, 2022
- 2 min
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, 2022
- 2 min
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, 2022
- 2 min
FMEA is Not Risk Analysis!
FMEA is not suitable as a tool for risk analysis.
38 views0 comments
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...
99 views0 comments
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...
304 views0 comments
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?
174 views0 comments
Simon Föger
- Apr 1, 2022
- 6 min
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
40 views0 comments
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