The 5 Most Common Calibration Pitfalls You Should Avoid in MedTech
A quick search of the FDA warning letter database shows more than a dozen entries around 21 CFR 820.72. Calibration is a well-understood...
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All About MedTech Blog
Sophia Hurmann
- Apr 11
- 3 min
Supplier Management in MedTech – The 7 Most Important Advantages 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 Certification
ISO 13485 is an internationally recognized standard for quality management systems specifically designed for the medical device industry....
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Simon Föger
- Mar 9
- 4 min
6 Reasons Why Your Technical Understanding is Essential to Validate Processes in MedTech
Process validation ensures that manufacturing processes reliably produce products that meet predetermined specifications and quality...
14 views0 comments
Bernhard Lindner
- Feb 23
- 2 min
The 4 Most Common Mistakes in the Risk Acceptance Matrix
In the past, medical device manufacturers have used risk acceptance matrices with large green areas where the occurrence of damage was...
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Sophia Hurmann
- Feb 14
- 4 min
Vietnam – a Sourcing Country for the Medical Device Industry?
The strategic decision of where to source materials is becoming increasingly difficult. The trade war between the U.S. and China, the...
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Bernhard Lindner
- Jan 19
- 2 min
Risk acceptance threshold: How many deaths are we willing to accept?
There are increasing reports from the field that insufficiently justified risk acceptance limits have led to problems with product...
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M.F. Siddiqui & S. Hurmann
- Dec 29, 2022
- 5 min
3 strategies to make your supply chain more resilient as a MedTech-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
In the MDR, the benefit-risk ratio is given a much higher priority than was the case in the MDD. The frequency with which the term...
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Bernhard Lindner
- Nov 17, 2022
- 2 min
How to minimize risks "as far as possible" in MedTech
The MDR demands in Annex I that medical device manufacturers must minimize risks "as far as possible". In this context, medical device...
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Bernhard Lindner
- Nov 3, 2022
- 2 min
FMEA is not risk analysis!
Over the past few decades, medical device manufacturers have used FMEA (Failure Mode and Effects Analysis) as a risk analysis tool....
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Simon Föger
- Oct 20, 2022
- 3 min
Test Method Validation of Pass/Fail Test Systems
... no matter whether they are destructive or not. In this last blog post about Test Method Validation, we discuss the validation...
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Simon Föger
- Oct 6, 2022
- 3 min
Test Method Validation of Continuous Destructive Measurements
Also known as Gage Reproducibility study! In the previous blog post about Test Method Validation for continuous non-destructive...
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Simon Föger
- Sep 28, 2022
- 4 min
Test Method Validation of Continuous Non-Destructive Measurements
Also known as Gage Repeatability and Reproducibility! In the previous blog post about Test Method Validation, we already discussed...
33 views0 comments
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...
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Simon Föger
- Jul 19, 2022
- 2 min
Performance Qualification (PQ) – Run 3 batches and ready, right?
Great, you finished the Operational Qualification (OQ), found your process window, and now must show the consistency of your process. The...
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Simon Föger
- Apr 1, 2022
- 6 min
Cultural differences… And how to not let them become an issue by using Erin Meyer's culture map
When working with people from different cultural backgrounds, we sometimes think we can work together just like we do with people from...
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Simon Föger
- Jan 11, 2022
- 4 min
Operational Qualification (OQ)
The fun part of medical device process validation! Great, you finished the installation qualification (IQ) and now want to start with the...
365 views0 comments
Simon Föger
- Nov 2, 2021
- 3 min
Installation Qualification (IQ)
Ticking-off as a necessary evil or to build a strong foundation? Do you think Installation Qualification (IQ) is the least important part...
125 views0 comments
Simon Föger
- Oct 3, 2021
- 4 min
Medical Device Manufacturing: Are you familiar with Process Validation?
Yeah, sure, it's IQ, OQ, and PQ! What's really behind these acronyms that everyone believes to know! Does your customer suddenly want you...
233 views0 comments
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