eBook | Ins and Outs of software as a Medical Device

Learn key technology and regulatory aspects to consider in MDSW life cycle management in this eBook. 

Learn key technology and regulatory aspects to consider in MDSW life cycle management in this eBook. 
September 3, 2021

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?

In this eBook, we will go 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 an in vitro diagnostic software. We will also review 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). An end-to-end vision for the “ideation to the CE certification” process for a software product.

Learn key technology and regulatory aspects to consider in MDSW life cycle management in this eBook. 

About Asphalion: Asphalion is an international scientific and regulatory affairs consultancy that collaborates with Pharma, Biotech and Medical Devices companies offering services from early development throughout the registration, until marketing and post-commercialization phases. In particular, Asphalion medical devices regulatory experts provide comprehensive support during development, validation, certification and manufacturing of Medical Devices products in Europe.

For further information you can contact us at: info@asphalion.com

Asphalion eBook Software as Medical Device


Search News & Events

  • Filter by category


Related news and events

NEWS | New Insight on the Implementation of MDR Article 17

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

The European Union’s AI Act & its Impact on Medical Devices

The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR).

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting