News

When Software is a Medical Device: What the Medical Device Regulations Say

Published on: 07/06/2021

When Software is a Medical Device: What the Medical Device Regulations Say
Member News

You can enjoy full access to the most recent interview about the classification of medical software and the concept of software as a medical device (SaMD) as it appears in Rule 11 of Annex VIII of the EU Medical Device Regulation. You’ll hear answers to the following questions and so much more, including
How is medical software classified?
What are the key points about software as a medical device in the new European Medical Device Regulation?
What are some examples of software as a medical device that would be classified as Class I, Class IIa, Class IIb, and Class III?

Watch the complete video interview and find the answers to these questions, click here:

Discover ArrowFast

As medical device engineering specialists, ArrowFast helps MedTech startups from planning to developing their device. Our team of 200+ engineers makes sure that the development is done at a fixed budget and in line with medical device regulations. With 20+ years of experience, we serve partners across the globe.

NEWS​

Related News

HLTH Brought the Energy to Amsterdam. Now It’s Vegas’ Turn.

26 Jun 2025
Next up: HLTH USA, October 19–22 in Las Vegas.

From Abandonment to Belonging: Hands 4Life’s Vision for Generational Healing

26 Jun 2025
Hands 4Life is a nonprofit organization addressing the global aging crisis by empowering communities in economically developing nations—beginning with...

Strengthening Elderly Care Innovation Across Europe: ECHAlliance at the NOTRE Project Meeting in Lille

26 Jun 2025
ECHAlliance participated in the latest partner meeting of the NOTRE Project, hosted in Lille, France by our Hauts-de-France ecosystem led by Eurasanté...

Africa Health Business Co-founder Dr Amit Thakker Honoured with Top Civilian Award

26 Jun 2025
Dr. Amit N. Thakker, Co-founder of our partner Africa Health Business, receives one of the highest civilian awards from the President of Kenya.

Highlights from the Global Health Connector Partners Programme at HLTH Europe 2025

25 Jun 2025
Our Global Health Connector Partners Programme returned to HLTH Europe this June with an energising series of sessions, conversations and connections ...

That’s a Wrap from HIMSS Europe 2025!

24 Jun 2025
From Paris with purpose: Gnomon Informatics SA returned to HIMSS Europe for a third year of bold ideas, smart tech, and stronger-than-ever momentum in...

Become a member

Join ECHAlliance to amplify your organisation’s message, grow your networks, connect with innovators and collaborate globally.
 
First name *
Last Name *
Email Address *
Country *
Position *
First name *
Last Name *
Email Address *
Country *
Position *