Quality Management
Regulatory Affairs
in Medical Devices


Training for Quality Engineers

Although Quality Engineers are present in many companies today, it is often unclear what Quality Engineering really means. This presentation will give practical guidance to training of quality engineers.

2010-06-03 16:47:38

Freelancing and Contracting

As freelancer I am able to support you short-term in the area of Quality Engineering. I am used to work hands-on in the shop floor, trying to design quality into your processes and products. Good medical device quality starts with calibration and adequate process development. Risk based production control plans and process monitoring will ensure long term stability. If needed, I can support Quality Engineering work onsite, aiming for pragmatic results improving product and process quality .

2013-10-10 07:31:44

Acceptance criteria for process capability indexes generated from statistical tolerance intervals as per ISO 16269-6

This statement intends to evaluate, if acceptance criteria for process capability Indexes could be generated from statistical tolerance intervals calculated as per ISO 16269-6. It is not intending to question or challenge the approaches as such.

2016-02-18 22:28:04

Unique Device Identifier

Do you know the “Basic-UDI-DI”? The European Union introduced the UDI for medical devices as per MDR 2017/745. When looking into the details one may not expect too many differences versus the UDI introduced recently by the US FDA. However, some differences exist. Download the document on this page and read more!

2018-03-03 14:49:47

Anforderungen an Klebeprozesse

Klebeprozesse sind allgegenwärtig in der Medizintechnik. Schade eigentlich, dass nicht alle über die detaillierten Anforderungen an diese Prozesse nachdenken. Dabei könnte die branchenunabhängige „Klebenorm“ DIN 2304-1:2016 helfen. Diese Norm, abgeleitet aus der DVS 3310 Richtlinie, gibt zahlreiche Hintergründe und Anforderungen an Klebeprozesse. Mehr Informationen finden Sie im nebenstehenden Dokument auf dieser Seite.

2018-03-03 14:53:27

Acceptance criteria for Gauge R&R studies

I recently added the statistical paper to my webpage intending to evaluate, if acceptance criteria for Gauge R&R studies could be generated from statistical tolerance intervals calculated as per ISO 16269-6. Any feedback would be appreciated!

2019-07-14 18:55:09

Checklist for changes

Changes to design, manufacturing and QMS must be documented and evaluated. The checklist changes (Checkliste Änderungen) will support such activity.

2021-02-03 08:05:32

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