Watch me while I create a complete Technical Documentation.
IEC 62304: Software Development
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
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
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
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).
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.
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.
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.
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.
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.
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!
Features
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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one-time price
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