Training day on Medical Devices- On Wednesday 29 November, the Gabinete Técnico Farmacéutico M. Camps organised in the COFBtogether with INTERCERa conference on the most relevant aspects of the new Medical Devices Regulation (EU) 2017/745.
The key points of the recently published regulation were discussed: the novelties introduced in Medical Devices. Among them, the Technical File and the clinical evaluation of these products. In addition, the following issues have also been discussed software and health appsand an overview was given of the ISO 13485:2016 y 10993.
The course was attended by around 30 participants, members of the technical departments of various companies in the sector. The aim of the course was to provide practical and clear information on the placing on the market of Medical Devices from 2020, when the new regulations will come into force for the whole of the Eurozone.
The speakers at the Training Day on Medical Devices: from left to right, Joaquim Gómez, Montse Figueras, Mercè Camps, Carlos González, Jorge Pérez and Ramon López.
The day's programme: Medical Devices Regulation and ISO standards in the sector
In the morning, a presentation of the speakers and the agenda was given. And the training session began with a presentation by Mercè CampsThe second presentation was given by the expert in medical devices and director of GTF, on the changes introduced by the new Regulation. The second presentation, by Carlos GonzálezThe GTF technical department member focused on the content of the Technical File. Later on, he Ramon LópezOur clinical collaborator of GTF, gave a presentation on Clinical Assessment in the new Regulation. And finally, our technical partner Joaquim Gómezgave an introduction to software and apps for healthcare use.
After a lunch break, there were still two more sessions on ISO standards in the afternoon. The first was given by Jorge Pérez, an expert auditor in INTERCER. And he was in charge of talking about what's new in the new version of the ISO 13485:2016. The second lecture was given by the toxicology expert from UTOX-PCB, Angel Menargues. If applicable, he explained the biocompatibility tests according to the standard ISO 10993.
Conclusions of the Training Day on Medical Devices and future training proposals
At the end of the day, the conclusions of the event were presented. The training was then brought to a close and diplomas were awarded to the participants. After the success of this edition, the Gabinete Técnico Farmacéutico M. CampsWe hope to be able to repeat the programme on a regular basis from 2018 onwards.
Among our training proposals, we will soon also be running two courses on the ISO 13485. One for Internal Audit and the other for Chief Auditorboth accredited by ERCA. If you would like to receive more information about the training courses that we organise at GTF, please contact us at subscribe to our newsletter.