Regulation of the software as a medical device

Regulació del software com a medical device

Asphalion regulatory expert, Talyta Carteano, returns to our cycle of virtual meetings to address the specific regulation of these products

As a software developer, knowing the specific regulatory requirements applicable to the software as a medical device is essential for their validation and introduction to the market. On September 14, the TECSAM Network celebrates its 10th Breakfast & Learn, under the name “The regulation of software as a medical device”, with the aim of addressing this issue.

Whether you are in the development and clinical evaluation phase of your software as a medical device or if you are one step away from launching it on the market, you need to know all the regulations that surround this technology. On this occasion, Talyta Carteano, Medical Device Associate Director and Lead Auditor at Asphalion, a consulting firm specialized in regulatory issues in the biotechnological, pharmaceutical and medical sectors.

After passing through the 8th Breakfast and Learn (Medical devices and their regulation: what do we need to know?), where she shared with all the attendees reference information on how medical devices are classified and their regulation, Cartiano returns to this new virtual meeting to deepen in the softwares as medical devices.

We will know the regulatory criteria to discern when software is or is not considered a medical device, the different classification rules and all the legislation that software manufacturers must know to implement this type of technology.

Given the small number of organizations authorized to certify that software as a medical devices complies with the Medical Device Regulation (MDR), Cartiano will also refer to the requirements in terms of quality, the criteria for carrying out feasibility studies and clinical validation, and the essential aspects researchers must take into account for the commercialization of these products.

Do you want to know the regulatory path and the strategies to meet the regulatory requirements to develop your software? Sign up for this virtual session where you can resolve all your doubts regarding this issue.

The meeting will take place in a virtual format and with free access prior registration in this form, in which you can also write down questions that the rapporteur will answer on the day of the conference.

About the Breakfast & Learn

The Breakfast&Learn is a formative initiative dedicated to innovation, valorization and transfer with a special focus on mental health and technology, led by the TECSAM network with the collaboration of the Catalan mental health cluster, Cluster Salut Mental Catalunya (CSMC). These open meetings are expected to be a monthly space where knowledge is shared and synergies and networking are generated, where the speakers will be guests with expertise in the sector, including administration, research, the private sector, as well as users and families.

The meetings will focus on three major thematic areas: Tools for bringing society and research closer together (innovation, marketing, contact with the private sector, business models, spin-offs, empowerment of affected and user people…), tools for protecting research results (intellectual protection, patents, other protection models…), and tools for doing research with clinical research (ethical regulatory aspects, medical devices, digital tools, software…).


9 h – Welcome to the Breakfast&Learn by the TECSAM Network.

9:10 h – “Virtual session “Regulation of software as a medical device”, by Talyta Carteano, Medical Device Associate Director and Lead Auditor at Asphalion, a consulting firm specialized in regulatory issues in the biotechnological, pharmaceutical and medical fields.

9:45 h – Q&A.

10:00 h – End of the meeting

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