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!
BILLED MONTHLY
BILLED ANNUALLY
SAVE UP TO 15 %
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.
Basics
Full access to the entire MDU library of videos and templates
Number of included licenses
1
5
Templates QMS ISO 13485
Assessments
Certification of Knowledge
Video Lessons
Regulatory Framework
Regulatory Basics (4 videos)
Introduction to the legal system according to MDR (10 videos)
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)
Templates
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
Starter-Kit
Guidelines for utilizing MDU to achieve your goal
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