{"id":3121,"date":"2017-11-30T12:43:49","date_gmt":"2017-11-30T11:43:49","guid":{"rendered":"https:\/\/mcamps.com\/?p=3121"},"modified":"2017-11-30T13:37:30","modified_gmt":"2017-11-30T12:37:30","slug":"jornada-formativa-sobre-productos-sanitarios","status":"publish","type":"post","link":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/jornada-formativa-sobre-productos-sanitarios\/","title":{"rendered":"Training day on Medical Devices at COFB"},"content":{"rendered":"

Training day on Medical Devices<\/strong>- On Wednesday 29 November, the Gabinete T\u00e9cnico Farmac\u00e9utico M. Camps<\/strong> organised in the COFB<\/strong>together with INTERCER<\/strong>a conference on the most relevant aspects of the new Medical Devices Regulation (EU) 2017\/745<\/strong>.<\/p>\n

The key points of the recently published regulation were discussed: the novelties introduced in Medical Devices. Among them, the Technical File<\/strong> and the clinical evaluation<\/strong> of these products. In addition, the following issues have also been discussed software and health apps<\/strong>and an overview was given of the ISO 13485:2016<\/strong> y \u00a010993<\/strong>.<\/p>\n

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.<\/p>\n

\"Los

The speakers at the Training Day on Medical Devices: from left to right, Joaquim G\u00f3mez, Montse Figueras, Merc\u00e8 Camps, Carlos Gonz\u00e1lez, Jorge P\u00e9rez and Ramon L\u00f3pez.<\/p><\/div>\n

The day's programme: Medical Devices Regulation and ISO standards in the sector <\/strong><\/h2>\n

In the morning, a presentation of the speakers and the agenda was given. And the training session began with a presentation by Merc\u00e8 Camps<\/strong>The 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 Gonz\u00e1lez<\/strong>The GTF technical department member focused on the content of the Technical File. Later on, he Ramon L\u00f3pez<\/strong>Our clinical collaborator of GTF, gave a presentation on Clinical Assessment in the new Regulation. And finally, our technical partner Joaquim G\u00f3mez<\/strong>gave an introduction to software and apps for healthcare use.<\/p>\n

After a lunch break, there were still two more sessions on ISO standards in the afternoon. The first was given by Jorge P\u00e9rez<\/strong>, an expert auditor in INTERCER<\/a>. And he was in charge of talking about what's new in the new version of the ISO 13485:2016<\/strong>. The second lecture was given by the toxicology expert from UTOX-PCB<\/a>, Angel Menargues<\/strong>. If applicable, he explained the biocompatibility tests according to the standard ISO 10993<\/strong>.<\/p>\n

\"Jornada<\/p>\n

Conclusions of the Training Day on Medical Devices and future training proposals <\/strong><\/h2>\n

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 T\u00e9cnico Farmac\u00e9utico M. Camps<\/strong>We hope to be able to repeat the programme on a regular basis from 2018 onwards.<\/p>\n

Among our training proposals, we will soon also be running two courses on the ISO 13485<\/strong>. One for Internal Audit<\/strong> and the other for Chief Auditor<\/strong>both accredited by ERCA<\/strong>. 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<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"

Jornada formativa sobre Productos Sanitarios– El pasado mi\u00e9rcoles 29 de noviembre, el Gabinete T\u00e9cnico Farmac\u00e9utico M. Camps organiz\u00f3 en el COFB, junto con INTERCER, una jornada sobre los aspectos m\u00e1s relevantes del nuevo Reglamento (UE) 2017\/745 sobre Productos Sanitarios. En ella se ha hablado sobre las claves de la reci\u00e9n publicada normativa: las novedades introducidas […]<\/p>\n","protected":false},"author":1,"featured_media":3124,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[199,301,50],"tags":[319,203,800,804,802,798,517,806],"class_list":["post-3121","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-productos-sanitarios","category-formacion","category-noticias","tag-cofb","tag-gtf","tag-intercer","tag-iso-13485","tag-iso-134852016","tag-jornada-formativa-sobre-productos-sanitarios","tag-merce-camps","tag-reglamento-ue-2017745-sobre-productos-sanitarios"],"_links":{"self":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts\/3121","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/comments?post=3121"}],"version-history":[{"count":0,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/posts\/3121\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/media\/3124"}],"wp:attachment":[{"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/media?parent=3121"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/categories?post=3121"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mcampsco-cp176.wordpresstemporal.com\/eng\/wp-json\/wp\/v2\/tags?post=3121"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}