Medical devices experts join forces for on time MDSAP* readiness for Occlutech

Case study

Occlutech was founded in Germany in 2003, and has since developed into one of the world´s leading suppliers in the area of structural heart disease with products and projects for congenital defects, stroke prevention, and heart failure.

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Occlutech PFO Occluder, a medical implant used in a minimally invasive procedure to close a patent foramen ovale (PFO) in the heart

Results

100% MDSAP audit readiness achieved on time

Occlutech completed validation of all regulatory-relevant computer systems within a tight timeline and successfully passed the MDSAP audit without findings.

Dozens of systems validated in a single, lean project

More than a dozen computer systems, equipment, and spreadsheets were validated and qualified using a lean combination of CSV and equipment qualification aligned with GAMP®5.

Validated QMS without production disruption

Close collaboration between Körber consultants and Occlutech’s validation manager ensured continuous production and delivery while achieving full regulatory compliance.

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