• Telefon_grau +1 (301) 244-6335
  • CONTACT US
  • LOGIN

Plans and Pricing

Medical Device University has subscription levels for people involved at all levels of the
medical device regulatory process. 

Whether you need a brand new quality system, templates for technical documents, sharper regulatory knowledge, or all of the above
— MDU has a plan for you.

BILLED MONTHLY

BILLED ANNUALLY

SAVE UP TO 10 %

5 % Discount

5 % Discount

10 % Discount

Basic

TD-Pack

QM-Pack

Platinum

Access to all the video lessons you need to understand the regulatory framework.

Access to all video lessons and a full set of templates to write the complete technical documentation for your medical device.

Access to select video lessons and the full Quality Management system compliant with ISO 13485:2016 and FDA 21 CFR Part 820.

Access to the entire MDU including all our templates and video lessons, a turnkey Quality Management system compliant with ISO 13485:2016 and FDA 21 CFR Part 820.

Video Lessons

Regulatory Framework

Is your product a medical device?

MDR for Auditors

FDA-approval

Regulatory Basics

Technical Documentation

The technical file and intended use

Risk management according to ISO 14971

The software development according to IEC 62304

Usability engineering according to IEC 62366-1

IT-Security

Artificial intelligence (coming soon)

QM System

An introduction to QMS and ISO 13485

QM-Manual

QM-System: Processes and procedures

SOP Document Control

SOP Development

SOP Risk Management

SOP Management Review

SOP Internal Audits

SOP Purchasing

SOP Feedback-Measures

SOP Training

Computer system validation

Templates

Technical Documentation

QM System

Self-assessments

Certificates

* required fields