Johner Institut GmbH

Germany

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Johner Institut GmbH is a German regulatory and compliance consultancy specializing in medical devices, in vitro diagnostics (IVD), and medical software. Founded in 2013 by Prof. Dr. Christian Johner and headquartered in Konstanz, Germany, the company guides medical technology manufacturers through product development, regulatory documentation, and compliance strategies.

The institute provides design-level compliance consulting and technical documentation support for European market clearance under the Medical Device Regulation (EU-MDR) and In-Vitro Diagnostic Regulation (IVDR), as well as United States Food and Drug Administration (FDA) clearance paths including 510(k), De Novo, and Premarket Approval (PMA).

With a team of more than 120 specialists, Johner Institut combines regulatory advisory services, digital audit-readiness platforms (such as Auditgarant), and educational academies to streamline device engineering and international market authorizations.

Offer

Johner Institut GmbH offers end-to-end consulting, design review, and compliance verification services for medical hardware, active medical devices, and medical device software (SaMD):

FDA Regulatory Pathway Consulting: Strategy and dossier preparation for FDA premarket submissions, including 510(k) Premarket Notifications, De Novo requests, Premarket Approval (PMA), Pre-Submissions (Q-Subs), and guidance on 21 CFR Part 820 Quality System Regulation (QSR) / QMSR compliance.
EU-MDR & IVDR CE-Conformity: Preparation, audit, and structuring of technical documentation according to MDR 2017/745 (Annex II and III) and IVDR 2017/746 to achieve CE marking, classification assessments, and General Safety and Performance Requirements (GSPR) mapping.
Design Control & Systems Engineering Support: Regulatory guidance during the engineering lifecycle covering electrical safety (IEC 60601-1), software lifecycle processes (IEC 62304), and usability engineering (IEC 62366-1).
Risk Management & Cybersecurity: Implementation and review of risk management files pursuant to ISO 14971 as well as medical device cybersecurity compliance (IEC 81001-5-1 and FDA cybersecurity guidance).
Clinical Evaluation: Preparation of Clinical Evaluation Reports (CER) and performance evaluations compliant with MEDDEV 2.7/1 Rev. 4 and MDCG guidelines.

Johner Institut GmbH

Offer

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