Johner Institute | 11,929 followers on LinkedIn. Effortlessly navigate the medical device approval processes and market and quickly market your device world-wide. | Johner Institute helps medical device manufacturers to - compile, review and improve technical documentations: risk management files (ISO 14971), usability files (FDA, IEC 62366-1), software documentation (FDA, IEC 62304), physical safety (IEC 60601-familiy), clinical evaluations, artificial intelligence - establish, audit and improve quality management systems (ISO 13485, 21 CFR part 820) - perform usability testing in Europe and the USA - plan and conduct clinical investigations - perform post-market surveillance, regulatory affairs update