Interested in learning key technology and regulatory aspects to consider in Medical Device Software life-cycle management?

Learn from our experts the ins and outs of software as a medical device

The Journey from "Software" to "Medical Device"

Do you know if your software product acts as a Medical Device? Are you interested in what aspects are needed so your software product becomes regulatory compliant with the Software as a Medical Device Regulation in the EU? Are you interested in learning how technology and best practices can boost the design, release, maintenance and CE certification of your product?

Explore the video

A journey through different use cases to understand how the new EU regulation impacts on existing or new software products. You will see how a software product is classified in terms of software risk class, as a medical device software or as a in vitro diagnostic software. You will also see how you can embrace edge technologies (data) and fulfill a CE-compliant product development process under the new regulation (Medical Device Regulation - EU/2017/745 or In Vitro Diagnostic Medical Device Regulation - EU/2017/746).


ERNI – your partner for medical software development

ERNI is a Swiss Software Engineering with more than 25 years in med-tech building software solutions for our customers worldwide. We are ISO 13485 certified and our processes are following IEC 62304.Our Medtech portfolio has four main areas: Patient-centric digital solutions, Devices connectivity, Laboratory Instruments & Point of care & Robots, and, in addition, any kind of middleware solutions.

Read more about software developments in the scope of EU medical device regulation

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