Quality Management
Regulatory Affairs
in Medical Devices


Templates for Process Validation

The attached templates may be used for Process Validation activities. Trainings are available for process validation including workshops.

2013-01-06 16:15:48

Freelancing and Contracting

As freelancer I am able to support you short-term in the area of Process Validation. I am used to plan, execute and report IQ, OQ, PQ. Usually this is done in your facility, but can be done offsite too.

2015-03-21 22:10:49

TÜV SÜD expert regulatory guidance Process Validation

Validation of manufacturing processes for medical devices is a requirement in medical device regulations where the resulting process output cannot be or is not verified by subsequent monitoring or measurement. Activities needed are usually not limited to the validation of the manufacturing process itself but may include as well equipment qualification, computer system validation and test method validation. The TÜV SÜD guidance supports manufactures in fulfilling these regulatory requirements.

2017-10-30 17:34:19

Computersystemvalidierung in Qualitätsmanagementsystemen von Medizinprodukteherstellern

Die Validierung von Computersystemen ist keine neue Anforderung. Bereits seit 1996 fordert die FDA im 21CFR820.70(i) die Validierung von automatisierten System und Software, welche in der Produktion und/oder im Qualitätsmanagementsystem eingesetzt wird. Spätestens mit der Umstellung auf die neue ISO 13485:2016 wurde das auch in Europa klargestellt. Dennoch hadern viele Unternehmen noch immer mit einer pragmatischen Umsetzung dieser Anforderung. Diese Checkliste soll realistische Umsetzungsmöglichkeiten aufzeigen.

2018-07-27 08:08:15

Process Validation Injection Moulding - Free example for OQ!

Since years I observe that our Medical device industry is still lacking easy-to-follow examples for process validations. Many companies are struggling to understand the meaning and purpose of challenging the process under worst-case conditions (OQ). Simon Foeger and I therefore wrote an example for OQ which can be downloaded for free. It does not intend to be perfect or even bullet-proof and it will offer enough room to be developed further. Enjoy reading and have fun validating your own and real injection moulding process!

2019-05-22 06:20:52

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