Johner Institut

Johner Institut GmbH offers regulatory consulting, product testing, outsourcing of regulatory and administrative tasks, training, and software for manufacturers of medical devices and in vitro diagnostics (IVD). Its service lines include market access, quality and management systems, technical documentation, usability and IT security testing, and a RegTech line with Regulatory Radar and Post-Market Radar products.

The website names manufacturers of medical devices and IVD as its target customers, and cites customers in pharma packaging, medical software and diagnostics. Services are sold as consulting engagements, testing studies, outsourced roles such as US Agent, and seminars, e-learning and software subscriptions. The site also offers a free access request for Post-Market Radar.

The site lists offices in Konstanz and Frankfurt am Main, and a Johner Institute North America in Arlington, Virginia. Open job postings include sales, IT infrastructure and a usability research role for medical devices and IVD.

Product: Regulatory consulting, usability and IT security testing, outsourced regulatory roles, seminars and e-learning, and the Regulatory Radar and Post-Market Radar software.