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 designed MasterClass as a lower-cost entry point for individuals, or small companies who don't have five (5) employees to utilize the licenses included with MDU Digital or MDU JumpStart. However, MasterClass is the same as MDU Digital.

MDU JumpStart is "MDU Digital + a defined amount of 1:1 consulting time" MDU JumpStart is targeted for start-up companies, or companies that have no experience with the Regulatory process and/or developing a QMS.

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

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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