Johner Institute New Zealand Limited

as a subsidiary of johner institut gmbh in germany, the johner institute new zealand supports medical device manufacturers and their suppliers, such as software developers, software testers, etc., to > compile, review and improve technical documentations: - software documentation in accordance with iec 62304 and further guidelines also in relation to ai - product documentation in compliance with iec 60601-familiy, iso 10993-family and more - risk management files (iso 14971) - usability files (fda, iec 62366-1) - clinical evaluation > establish, audit and improve quality management systems (iso 13485, 21 cfr part 820) > perform usability testing in europe and the usa > perform post-market surveillance, regulatory affairs update with in- house seminars, we impart the necessary knowledge to your team. we act as a sponsor in new zealand for overseas medical device manufacturers.