Plans and Pricing

Upgrade your Medical Device Skills

The Medical Device University provides 200+ Videos, numberous Templates and Self-Assessments. With our pricing modells, we got the right choice for every costumer.

Not sure about the right option for you? Contact us!




MDU Masterclass

MDU + Jumpstart

We recommend the MasterClass as a lower-cost entry point for individuals, or small companies. You get access to all templates and video lessons in the MDU.

MDU JumpStart is "MDU Masterclass" + a defined amount of 1:1 consulting time with our Johner Institute experts. MDU JumpStart is suitable for start-up companies, or companies that have no experience with the Regulatory process and/or developing a QMS and to their products to the market faster.


Full access to the entire MDU library of videos and templates

Number of included licenses



Templates QMS ISO 13485


Certification of Knowledge

Video Lessons

Regulatory Framework

Is your product a medical device? (2 videos)

MDR for Auditors (12 videos)

FDA-approval (14 videos, task course)

Person responsible for regulatory compliance (12 videos)

Technical Documentation

The technical file (1 video)

The intended use (13 videos, task course)

Risk management according to ISO 14971 (16 videos)

Software development according to IEC 62304 (16 videos)

Usability engineering according to IEC 62366-1 (15 videos)

Clinical evaluation according to MEDDEV 2.7/1 Rev 4 (22 videos)

IT Security for medical devices (18 videos)

QM System

Introduction to QMS and ISO 13485 (4 videos)

QM-Manual (2 videos)

Processes and procedures (6 videos)

Document control (4 videos)

Development (8 videos)

Risk management (2 videos)

Management review (2 videos)

Internal audits (3 videos)

Purchasing (3 videos)

Feedback-Measures (4 videos)

Training (3 videos)

Computer System Validation (12 videos)


Technical Documentation

Technical File (10 templates)

Design Input (4 templates)

Software File (17 templates)

Risk Management File (12 templates)

Usability File / Human factors (5 templates)

Clinical Evaluation (9 templates)

Post-Market-Clinical-Follow-Up (2 templates)

Development (16 templates)

IVD-Performance Evaluation (12 templates)

Labeling (3 templates)

Biocompatibility (1 template)

QM System

QM-Manual (3 templates)

Management Review & Audit (10 templates)

Corrective and preventive actions (3 templates)

Document & Record Control (8 templates)

Human Resources & Training (6 templates)

Infrastructure (13 templates)

Development and Product Management (12 templates)

Supplier Management & Procurement (10 templates)

Production & Service Delivery (7 templates)

Change Management (3 templates)

Post-Market Surveillance, Feedback (11 templates)

Authorities and Regulatory Affairs (9 templates)

Jumpstart Consulting Program

Access to expert medical device consultants

3 x 60-minute collaborative virtual meetings

Detailed project plan


Guidelines for utilizing MDU to achieve your goal


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