schwind consulting gmbh

SCHWIND Consulting GmbH offers a wide range of cosnulting services for life science industry. We provide services and solution for QMS according international standards (e.g. FDA 21CFR820 QSR, ISO 13485) as well as services for CAPA, Qualification & Validation. As solution provicer, we offer also Risk Management in accordance to ISO14971 as well as System Engineering on High Level Structure down to grey boxes. Due our experience in development, testing and supporting medical devices (active as well as non active devices) we offer also a wide range of expertise in using several standards (e.g. IEC 60601-1 and several -2 standard families). We provide also services for 1st & 2nd party audits as well as mock-up audits for 3rd party requirements.