Medical device stand-alone software including apps (including IVDMDs)

Page 15

Guidance: Medical device stand-alone software including apps (including IVDMDs) v1.06

Concerning a congenital abnormality Software that gives information about an acquired or inherited condition or disease from results generated by an IVD. Results may be quantitative or qualitative and can be entered manually by the user or automatically from the IVD. Examples that may be devices include: • Apps and software that are intended for detecting and interpreting mutations in DNA • Apps and software that are intended for determining risk of trisomies

Indicative words and phrases:

DNA Genomics Data analysis Big Data Next Generation sequencing...

Back

Introduction

Device decision flow chart

Medical purpose flow chart

Medical devices

In vitro diagnostic medical devices

Active implantable medical devices

Non medical devices

Index

15


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.
Medical device stand-alone software including apps (including IVDMDs) by The British Healthcare Trades Association - Issuu