Medical Devices in Valencia – On Wednesday 27 November, a conference on the new Medical Devices Regulation was held in the auditorium at La Fe Hospital, attended by several technical staff members and the director of GTF, Mercè Camps.
On Wednesday 27 November, Gabinete Técnico Farmacéutico M. Camps took part, alongside other companies from the regulatory sector and healthcare professionals, in a training session on the new Regulation 745/2017 on Medical Devices organised by the ITEMAS Best Practices Working Group. The Regulation, which was published on 3 April 2017, will come into force in May 2020 and will directly affect legislation on medical devices and in vitro diagnostic (IVD) devices across the EU,
The event was organised by the La Fe Institute of Health Research and took place in the auditorium of La Fe UIP Hospital (Avd. Fernando Abril Martorell, 106). The event was funded by the Valencian Regional Government and the Valencian Agency for Innovation (AVI), and 230 of the 250 free places available on the course were filled.
Programme for the Medical Devices Conference in Valencia
9.00– 9.15 Reception for attendees
9.15 – 9.30 Opening.
Máximo Vento. Scientific Director of the La Fe Institute for Health Research. To be confirmed: Representative of the Regional Ministry of Universal Healthcare and Public Health.
9.30 – 10.15 Key aspects of the new Medical Devices Regulation
Maria Aláez. Technical Director of FENIN (Spanish Federation of Healthcare Technology Companies)
10.15 – 11.00 Legal Aspects of the New Regulation
Mayte Vázquez. Partner in charge of the Life Sciences Department (DA Lawyers)
11.00 – 11.30 Coffee Break
11.30 – 12.15 Drafting the Technical File: content, stages and key assessments/tests. Carlos González. M. Camps Pharmaceutical Technical Office
12.15– 13.00 Development and Validation of Medical Software and Apps
Xavier Canals Riera. Director of Tecno-med, a partner company of ITEMAS
13.00 – 14.00 Round Table: Placing a Medical Device on the Market. Current situation of the implementation and industry challenges.
Maria Aláez (Fenin), Joaquin Gómez (KIWA) and Mercè Camps (M. Camps Pharmaceutical Technical Office)
14.00 Closing
Máximo Vento Torres. Scientific Director of the La Fe Institute for Health Research
Conclusions of the Conference
Here at GTF, we greatly appreciate the teaching staff’s strong commitment, as well as the warm welcome we received and the success of the Medical Devices Conference in Valencia.
And we believe we have more than enough reasons:
- On the one hand, because of the opportunity we have had to take part in a training event in Valencia, one of the leading centres of the Spanish pharmaceutical industry, where Gabinete Técnico Farmacéutico M. Camps has recently opened a business premises.
- And secondly, because of the huge turnout at the training event, which once again demonstrates the major ‘boom’ currently being experienced by medical devices, health apps and, in general, everything related to the sector healthtech.
Following this rewarding experience with the Valencian healthcare community, we would like to point out that the new European Regulation aims to strengthen health safeguards, keep pace with technological developments, increase transparency and enhance the oversight and cooperation of health authorities.
And that it is only through the correct interpretation of the Regulation 745/2017 on Medical Devices And, of course, thanks to the gradual adaptation of companies, professionals and all the technical teams involved in ensuring the safety of patients and consumers, we will be ready by May 2020.
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