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Looking for Example Documentation?

Watch me while I create a complete Technical Documentation.

One of our most frequent customer requests was:

Where can I find example documentation from other companies?

Well, you can't. We don't share customer files, and companies typically don't publish their regulatory documents. But - I can create a new set of documentation for you and record videos while I do so!

Compared to other other regulatory seminars and trainings, these videos are hyper-concrete: It's literally me filling out documents and explaining them while I go along. This will enable you to write your own technical documentation once you've watched them.

The best part? All videos are based on our free templates, so you've already got access to those for getting started!

Some Free Sample Videos

IEC 62304: Software Development

Documenting Software of Unknown Provenance (SOUP)

Ready for some pain? We need to document our libraries because they're SOUP.

SOUP stands for Software of Unknown Provenance. In human language, those are your libraries. Nowadays, these are open-source libraries which you include in your package.json or Gemfile.

But how do you document it?

ISO 14971: Risk Management

Creating a Simple Risk Table

Let's get started with something straightforward: Thinking about what could possibly go wrong.

We'll be creating a simple risk table which will (hopefully) end up being a full-blown Failure Mode and Effects Analysis (FMEA).

IEC 62366: Usability Engineering

Creating a List of Hazard-Related Use Scenarios

Let's dive right into it and write down Hazard-Related Use Scenarios for the magic Covid Photo App.

Hazard-Related Use Scenarios are (usage) scenarios in which Hazards could arise (sounds obvious, right?).

We'll see whether we can come up with some scenarios for the magic Covid Photo App and how to document them.

Courses

List of All Courses and Videos

IEC 62304

Software Development

The IEC 62304 is about documenting your software and establishing processes which ensure that your software development is compliant. Among other things, that includes documenting your software requirements, software tests and libraries (SOUP - software of unknown provenance).

7:06
Introduction
10:15
Meet CrowdCovid
7:33
V-Model and Compliant Development
12:12
Writing a Software Development and Maintenance Plan
4:13
Why Software Requirements?
24:23
Writing Software Requirements for CrowdCovid
8:16
Software Requirements Review
21:51
Software Architecture Documentation
12:29
Implementation and Verification
13:00
SOUP (Software of Unknown Provenance)
free - click to watch
16:44
Software System Testing
8:03
Release
7:41
Change Management
3:42
Problem Resolution

ISO 14971

Risk Management

To be compliant with ISO 14971, you need to perform a risk analysis of your device, as well as establish risk management processes in your company.

12:51
Creating a Simple Risk Table
free - click to watch
19:18
Risk Acceptance Matrix
6:17
Preliminary Hazard Analysis
19:21
Failure Mode and Effects Analysis (FMEA)
18:03
Failure Modes
17:30
Risk Control Measures
5:22
Risk Management Plan
11:40
Risk Management Report
10:59
Risk Management in SOP Integrated Software Development
8:35
Improvements to Risk Management

IEC 62366-1

Usability Engineering

The main chunk of work for IEC 62366-1 compliance is performing usability tests with users. With those, you prove that your product is actually usable.

5:42
Getting Started with the 62366
13:22
List of Hazard-Related Use Scenarios
free - click to watch
4:22
Formative Usability Evaluations
14:44
Preparing the Usability Evaluation Protocol
12:12
Doing the Summative Evaluation - Usability Test
9:16
Usability Evaluation Plan
13:47
Usability Evaluation Report
8:10
Usability in SOP Integrated Software Development

ISO 13485

Setting Up Your QMS

I'll show you how to set up a simple Quality Management System (QMS) in Google Drive. Note that these videos don't cover the entirety of ISO 13485.

10:11
Google Drive Example QMS
11:38
SOP Document and Record Control
6:34
Relevant Roles
12:55
Quality Manual, Policy, Objectives

MDD

Medical Device Safety Officer Training

For the old legislation in Germany (MDD / MPG), you needed a so-called Medical Device Safety Officer. That person needs to have an idea of what his/her obligations are. You can use these videos to teach yourself and create a PDF certificate.

4:45
Introduction
9:02
Legal Requirements
15:42
Tasks and Responsibilities, Example
4:13
Examples
2:50
Conflicts of Interest, Liability
6:48
External People, MDR Outlook

MDD

Medical Device Consultant Training

Similar as the Medical Device Safety Officer, the MDD / MPG had a requirement for so-called Medical Device Consultants. Typically, those are your salespeople and people in customer support. They also need to be trained.

10:40
Requirements, Tasks, Responsibilities
9:39
Examples

Germany / BfArM

BfArM Registration

For one of our customers, we brought a medical device to market. That gave me the unique opportunity to walk you through the process of navigating the slightly confusing BfArM / DIMDI registration system!

10:18
Getting a User Code
11:02
Company Information and MDSO
11:26
Submitting Your Product

Features

Hyper-concrete videos and super-fair, one-time payment. Unlimited seats included.

Hyper-Concrete

I'm not rambling about abstract regulations - you'll watch me fill out documents and create technical documentation for a "real" medical device.

Invite Your Team

You can invite an unlimited amount of users. That means you'll be able to invite everyone from your team!

Unlimited Access

You get access to the videos, forever. Come back anytime to re-watch videos.

PDF Certificates

Download a PDF certificate of your accomplishments and use that as training documentation for your QMS.

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Calculate Your Price.

Step 1: How Big Is Your Company?

Your Company Headcount

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Step 2: Which Video Courses?

BfArM Registration

Register your Medical Device at the BfArM! And learn how to navigate the sometimes confusing DIMDI / BfArM form system without making mistakes.

free

QMS Basics in Google Drive

Get started on setting up a lean Quality Management System (QMS) in Google Drive, no expensive software required!

free

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one-time price

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