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MedTech Blog

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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The 4 Most Common Mistakes in the Risk Acceptance Matrix

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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Vietnam – a Sourcing Country for the Medical Device Industry?

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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Risk Management for Medical Devices: How Many Deaths Are We Willing To Accept?

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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FMEA is Not Risk Analysis!

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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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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Cultural Differences in International Business… And How To Not Let Them Become an Issue

Apr 1, 20226 min read

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

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Operational Qualification (OQ)

Jan 11, 20224 min read

Operational Qualification (OQ)

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

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

Oct 3, 20214 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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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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