Learn key technology and regulatory aspects to consider when building your Medical Device Software products
📆June 8th, 🕛 9:30- 11:00 CEST
About this event
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?
We will go through different use cases to understand how the new EU regulation impacts on existing or new software products. We 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).
This session will be led by ERNI experts and Asphalion experts Dominique Monferrer and Talyta Carteano. They will offer an end-to-end vision for the “ideation to the CE certification” process for a software product.
About ERNI: ERNI is an international software engineering company, with long experience building digital solutions for patients and people health. ERNI is ISO 13485 certified and demonstrates a strong track record of customer success stories on regulated environments, such as med-tech, pharma and healthcare. For more info visit: https://www.betterask.erni/
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 more info visit: https://www.asphalion.com/
You can also contact us at: email@example.com
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