Hiring or looking for a job in Digital Health? Check out our Digital Health Jobs board

Templates IEC 62304 Templates

November 15, 2023

Template: Instructions On Data Acquisition (Machine Learning / AI)

Sven Piechottka

Template Download

This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, choose "QMS" on the top menu and "OpenRegulatory Templates" on the left menu, and then open the relevant folder to find this template ready to load into Formwork.

If, for some mysterious reason, you're using a different QMS Software, you can also simply download this template - specifically, as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don't remove the copyright at the bottom).

Download as Word File

docx

Download as PDF

pdf

Copy-paste to Google Docs

html

Download as Markdown

md

Tired of copy-pasting? If you want to save time and edit these templates directly, you can use Formwork, our eQMS software. And if you're looking for step-by-step instructions for filling them out, check out our Wizard :)

Don't Miss Updates to This Template

Subscribe to our newsletter and we'll keep you posted on which templates we've changed.

Questions? Still Lost in Regulation?

Good news! Our goal is to provide lots of stuff for free, but we also offer consulting if you need a more hands-on approach. We get stuff done really fast. Have a look!

Template preview

Instructions on Data Acquisition

The Instructions on Data Acquisition define what kind of data is collected and annotated (prepared) for machine learning model development. The requirements for general data acquisition can be defined less specific than the subset of data used for annotations as any additional data can be used for future developments that are not specified yet.

Relevant other documentation:

Acquisition

Use Context

   
Use context: <e.g. AI-based decision support in radiology>
Pathology: <e.g. prostate cancer>
Target numbers: For example: XXX tumor cases with biopsies, XXX benign cases, XXX healthy cases
Other information: <For example: Prefer images from certain manufacturers>
(…) (…)

Medical Specifications

   
Patient population: <For example: European male>
Contents of medical reports: <Applicable clinical scores, biopsy information, etc.>

Technical Specifications

   
Manufacturer: <Enter hardware manufacturer, e.g. Siemens>
Exclusions: For example: images other than MRI, no medical reports included
(…) (…)

Annotation Data

   
Inclusion criteria: For example: male patients in Europe with certain diagnoses, (…)
Exclusion criteria: For example: tumors caused by metastasis of other cancers, implants e.g. for radiation therapy, (…)

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.


Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

No QMS on this planet will save you from creating crappy software.