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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.
Risk Management of Medical Devices: How to Create a MedTech-Compliant Risk Management System According to ISO 14971:2019
Learn how to build your risk management system for medical devices in compliance with ISO 14971.
Bernhard Lindner
Mar 2513 min read
52 views
0 comments
Developing Robust Visual Inspection Processes in the Medical Device Industry
Visual inspection is a cornerstone of quality assurance in the medical device industry, ensuring product integrity, patient safety, and...
Simon Föger
Jan 177 min read
221 views
0 comments
Test Method Development
Test methods don't fall from the sky – we have to develop them. We often talk about test method validation, but we rarely address test...
Simon Föger
Dec 6, 202411 min read
208 views
0 comments
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
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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
397 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
265 views
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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
77 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
256 views
0 comments
Supplier Management in MedTech – Top 7 Benefits of Working with a Trading Partner
MedTech Supplier Management: 7 Benefits of Working with a Trading Partner
Sophia Hurmann
Apr 11, 20233 min read
25 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
The 4 Most Common Mistakes in the Risk Acceptance Matrix
The 4 Most Common Mistakes in the Risk Acceptance Matrix & How To Avoid Them!
Bernhard Lindner
Feb 23, 20232 min read
65 views
0 comments
Sourcing in Vietnam: A Rising Opportunity for the Medical Device Industry?
Sourcing Decisions – How important is Vietnam as a sourcing country for medical device manufacturers?
Sophia Hurmann
Feb 14, 20234 min read
44 views
0 comments
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...
Bernhard Lindner
Jan 19, 20232 min read
46 views
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3 Strategies to Make Your Supply Chain More Resilient as a Medical Device SME
The pandemic has exposed supply chain vulnerabilities and forced us to revise old strategies. What once worked now no longer does....
Sophia Hurmann
Dec 29, 20225 min read
56 views
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The Underestimated Value of "Clinical Benefit" in Medical Device Risk Management
The Underestimated Value of "Clinical Benefit" in Medical Device Risk Management
Bernhard Lindner
Dec 1, 20222 min read
39 views
0 comments
How To Minimize Risks "as far as possible" in MedTech
How to minimize risks "as far as possible" when producing medical devices.
Bernhard Lindner
Nov 17, 20222 min read
47 views
0 comments
FMEA is Not Risk Analysis!
FMEA is not suitable as a tool for risk analysis.
Bernhard Lindner
Nov 3, 20222 min read
93 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
537 views
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