EU, Switzerland and USA.
The Johner Institute supports manufacturers of medical devices, in particular of devices with embedded software or stand-alone software. In this domain the Johner Institute is the leading consultancy firm in the largest European market — the German speaking countries. With no exception, all of Johner Institute’s customers (several hundred) passed audits, inspections and submissions successfully. Professor Johner’s team consists of highly specialized experts in the below mentioned areas of support.
Areas of regulatory/reimbursement support:
Regulatory affairs; FDA approval; CE-marking; Quality management systems; Medical devices with embedded software or stand-alone software; Software engineering and software processes; Risk analysis, assessment and management; Clinical evaluations; Requirements & usability engineering; Usability testing in own usability labs in the USA and Germany.