It also applies to medical devices for which clinical data is not deemed appropriate,9to demonstrate conformity with Annex I, and the demonstration of an adequate justification for … April 27, 2013 | By Márcio Barra. Clinical Evaluation Plan The Clinical Evaluation Plan must include information concerning the safety or performance of the medical device that is generated from actual use of the device. EAP guidance could be organized. Clinical trials are fundamental to the development of innovative, investigational products such as drugs or high-risk (and some medium-risk) medical devices.*. Für die klinische Bewertung von Software gelten die gleichen gesetzlichen Anforderungen wie für die klinische Bewertung aller Medizinprodukte. The MAPS Medical Affairs Strategic Planning Guide and Template has been developed to provide guidance and recommendations to selected components that comprise the strategic medical affairs planning for a product – including the situational analysis, medical strategy, tactical/operational planning, and medical plan summary. You can start creating your medical sales 30-60-90 day plan with either a template or by making your own plan. art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device - Clinical development plan indicating progression … Medical Device Development Business Plan [Sample Template for … Clinical Development Plan - DCVMN Developing protocol: Concept protocol – template. Initial phase from which Design Control starts is Design Input development and approval, which consists of device design and manufacturing processes to be carried out in the production phase. Medical Device