Whether launching or further developing a quality management system according to ISO 9001:2015, ISO 13485:2016, or FDA Quality Systems Regulations (21 CFR 820), inmedis offers you the appropriate support to keep your quality management system compliant but lean. Whether you want to prepare yourselves for the MDR or would like to have an assessment of your current situation we carry out analysis audits (e.g. MDSAP) and show you where action is needed.
The simplification of work flows and effective definition is a strength of our company. We guide you through the individual phases of your project to successful certification in clear manageable steps.
„Thanks again from my side for the great support and advice with a sense of proportion. The way you dealt with the topic and made us aware of the important issues efficiently and purposefully was great and we would recommend it anytime!”