Medical Device Software is a rapidly evolving field in the MedTech industry and requires specific considerations for the Clinical Evaluation Report and the State of the Art Evaluation.<\/p>\n
MDCG 2019-11 helps with the specific classification rules for Medical Device Software, whereas MDCG 2020-1 provides recommendations for the clinical evaluation strategy.
\nHowever, clinical evaluations for medical software can be less straightforward than for hardware devices.<\/p>\n
Participants will get a brief overview of the regulatory framework in the European Union for Medical Device Software. After that, we will take an in-depth look at how to discuss valid clinical association, technical performance, and clinical performance of Medical Device Software in the clinical evaluation.<\/p>\n
The workshop will also discuss the challenges of writing State of the Art Evaluations, identifying benchmark parameters, and defining clinical benefits for Medical Device Software.<\/p>\n
It will be an interactive training with team exercises and room for questions and discussions.<\/p>\n","protected":false},"excerpt":{"rendered":"
Medical Device Software is a rapidly evolving field in the MedTech industry and requires specific considerations for the Clinical Evaluation Report and the State of the Art Evaluation. MDCG 2019-11 helps with the specific classification rules for Medical Device Software, whereas MDCG 2020-1 provides recommendations for the clinical evaluation strategy. However, clinical evaluations for medical … Continued<\/a><\/p>\n","protected":false},"featured_media":9082,"template":"","meta":[],"product_brand":[],"product_cat":[46],"product_tag":[],"class_list":["post-13080","product","type-product","status-publish","has-post-thumbnail","course_topics-dispositivi-medici","course_types-corso-online","productgroup-medical-device-software","product_cat-corsi","first","instock","taxable","shipping-taxable","purchasable","product-type-variable"],"_links":{"self":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product\/13080","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media\/9082"}],"wp:attachment":[{"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/media?parent=13080"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_brand?post=13080"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_cat?post=13080"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lsacademy.com\/en\/wp-json\/wp\/v2\/product_tag?post=13080"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}