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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.

When More IS Better – Process Variation & Sample Sizes

Jun 13, 20243 min read

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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How The EU MDR Changed The Landscape of Process Validation

Mar 11, 20243 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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A Guide to Worst-Case Testing in MedTech

Oct 30, 20233 min read

A Guide to Worst-Case Testing in MedTech

The Art and Science of Defining Worst-Case Tests in MedTech.

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Medical Device Audits: A Typical Day in the Shoes of an Auditor

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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Equipment Maintenance Plans in MedTech – 5 Reasons Why You Should Avoid DIY Maintenance Plans

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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The 5 Most Common Calibration Errors You Should Avoid in MedTech

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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Why Your Suppliers Do Not Need an ISO 13485 QMS Certification

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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6 Reasons Why Your Technical Understanding is Essential for Process Validation in MedTech

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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Attribute Agreement Analysis (Go/No Go Gage or Pass/Fail Test Systems)

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.

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Destructive Test Methods: Gage Reproducibility Study (TMV of Continuous Destructive Measurements)

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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Conducting a Gage R&R Study with Minitab (Explained with a Practical Example)

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.

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Test Method Validation (TMV) in Medical Device Manufacturing

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.

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Performance Qualification (PQ) – Run 3 Batches And Ready, Right?

Jul 19, 20222 min read

Performance Qualification (PQ) – Run 3 Batches And Ready, Right?

Performance Qualification (PQ) – Run 3 batches and ready, right?

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Operational Qualification (OQ)

Jan 11, 20225 min read

Operational Qualification (OQ)

Operational Qualification (OQ) – The fun part of medical device Process Validation!

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Installation Qualification (IQ)

Nov 2, 20213 min read

Installation Qualification (IQ)

Installation Qualification (IQ) in MedTech – Ticking off as necessary evil or to build a strong foundation?

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Process Validation in Medical Device Manufacturing: How Familiar Are You With IQ, OQ, and PQ?

Oct 3, 20215 min read

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.

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Process Validation Sample Size – Cpk of 1.33 is not enough!

Sep 20, 20215 min read

Process Validation Sample Size – Cpk of 1.33 is not enough!

Process Validation Sample Size – Cpk of 1.33 is not enough!

1,624 views0 comments

Statistical Tolerance Intervals – Explained simply and practically based on ISO 16269-6

Sep 7, 20215 min read

Statistical Tolerance Intervals – Explained simply and practically based on ISO 16269-6

Statistical Tolerance Interval in MedTech – Explained based on ISO 16269-6

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