Company intelligence
Johner Institute
Effortlessly navigate the medical device approval processes and market and quickly market your device world-wide.
About Johner Institute
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
Verified activity
Signals from Johner Institute
8 published signals
Research & Knowledge
Johner Institute conducted a usability study that failed to meet MDR, IVDR, or FDA requirements, leading to additional costs for labor, participant recruitment, moderation, and analysis, and delaying market entry.
Reported by Johner Institute
Presence & Recognition
Johner Institute presents selected online events in the newsletter including a workshop, seminar, seminar, webinar with Medcrypt on KI and cybersecurity, and seminars from GBA Group MedTech Solutions.
Reported by Johner Institute
Presence & Recognition
Johner Institute offers six curated tracks for the Medical Consultation Day in Berlin on September 30 and 1.
Reported by Johner Institute
Presence & Recognition
Johner Institute experts are available at Stand 66 in Hamburg from September 30 to October 2 for IVDs, performance evaluation, and regulatory requirements.
Reported by Johner Institute
Presence & Recognition
Johner Institute colleagues are attending the MedicalMountains GmbH event in Tuttlingen on September 7th.
Reported by Johner Institute
Presence & Recognition
Johner Institute North America Inc. is hosting a conference in Charlotte, North Carolina from September 15 to 17, featuring sessions on regulatory strategies, usability, and US market entry challenges.
Reported by Johner Institute
People
Johner Institute welcomed Dennis as a Werkstudent and Tan as an Ausbildender in the IT-Bereich at their new location in Konstanz.
Reported by Johner Institute
Presence & Recognition
Johner Institute is hosting its MDD-Sessions at the Berliner Spreespeicher in a full schedule.
Reported by Johner Institute