Quality Management

STRATEC Succeeds When its Partners Succeed

The STRATEC Group is committed to continually enhancing its processes and service quality. One of STRATEC’s fundamental obligations is to structure its business processes so that it and its partners – diagnostics and life science companies operating in highly regulated worldwide markets – meet regulatory and legal requirements in a continually changing environment. STRATEC’s commitment to satisfy regulatory standards enhances its partners’ positions in their respective markets.

STRATEC’s success is derived from the economic viability of its partners. Clearly defined processes throughout the value chain, from the initial development steps through to serial production, play a crucial role in safeguarding permanent market success. At the same time, a flexible quality management system also facilitates compliance with the necessary international requirements enabling STRATEC to work together with its OEM partners to access new markets rapidly and efficiently.

STRATEC’s complaint handling system supports the service and vigilance process – as well as its partners’ risk management – by offering interdisciplinary error analyses and risk assessments. Additionally, STRATEC actively involves its partners in relevant control steps within the change process.



STRATEC SE --- MDSAP certificate

STRATEC Switzerland AG --- EN ISO 13485

STRATEC Consumables GmbH --- EN ISO 13485


QM System compliant with 21 CFR part 820

FDA registered establishment

NRTL registered (NEMKO, UL)

Compliance with GMP requirements of Taiwan (TCP participation)

Foreign Manufacturer Accreditation by PMDA / Japan

Compliance with QMS requirements in several other markets

Medical devices registered with UK MHRA