Medical devices and their regulation: solving doubts
On Wednesday, 1 June at 9 a.m., we celebrated the 8th Breakfast & Learn of the TECSAM Network, where we will learn to identify what is and what is not a medical device, and we will examine the regulation governing these technologies.
The offer of new health products, processes and services oriented toward medical purposes are subject to very specific legal regulations before they are placed on the market. In order to deepen this theme, the TECSAM Network organizes the virtual day “Medical devices and their regulation: what do we need to know?”.
One of the most obvious effects of the progressive convergence between health, research and business have been the development of new technologies applicable to the health sector,generally known as medical devices (MD). However, it is often difficult to know how the regulation and definition of these new technologies work.
In this meeting, Talyta Carteano, Medical Device Associate Director & Lead Auditor at Asphalion, a Scientific and Regulatory Affairs Consultancy in the Pharma, Biotech and Medical fields, will resolve questions live and provide reference information on what is and what is not a medical device (including, apart from materials, devices or equipment, also software), how to identify them and how they are classified.
One of the central topics of this conference, which is part of the Breakfast & Learn that organizes the TECSAM Network monthly, is the process of creating medical devices and the steps to follow to develop clinical trials and research including these technologies.
With the help of Carteano, we will be able to know all the regulations that teams must take into account to start projects with medical devices: from manufacturing regulations, ethical regulatory processes and obtaining licenses.
During this session, all attendees, whether or not they belong to the field of clinical research, will be able to know all the generalities surrounding the medical devices, as well as get deeper into the regulation governing these technologies.
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…).
PROGRAM:
9 h – Welcome to the Breakfast&Learn by the TECSAM Network. 9:10 h –”Medical devices and their regulation: what do we need to know?”, in charge of Talyta Carteano,Medical Device Associate Director & Lead Auditor at Asphalion, a Scientific and Regulatory Affairs Consultancy in the Pharma, Biotech and Medical fields
9:45 h – Q&A.
10:00 h – End of the meeting.
