Johner Institut GmbH

Johner Institut GmbH is a consulting, training, research and software company that acts as a regulatory partner to medical device manufacturers. Its work spans regulatory science, medical device regulation, technical documentation, management systems, post-market surveillance and market access consulting, with the aim of helping firms bring safe and effective devices to market faster while maintaining compliance and quality. The company has been operating for over two decades and serves manufacturers worldwide.

The firm combines this advisory work with a RegTech product portfolio. Regulatory Radar provides regulatory monitoring and intelligence for manufacturers, while Post-Market Radar supports post-market surveillance activities. Auditgarant offers assisted self-service regulatory support, and the Johner Academy runs educational programmes and training for medical device companies.

Johner Institut describes itself as a sought-after consulting firm in medical technology. It was founded on a combination of interests in software development, medicine and regulatory science, and states a mission of balancing scientific excellence with social benefit in the interest of better healthcare outcomes. Its approach is holistic, combining consulting, training, research and software, with a stated focus on enabling innovation without sacrificing compliance or quality.