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: [email protected]
Asphalion eBook Software as Medical Device
