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Research & Development<\/p>\n<\/div>\n
We turn the customer’s idea into a finished product<\/p>\n<\/h1>\n
<\/span><\/span>For research and development, prototyping, and the realisation of pilot batches, Enable Innovations uses a state-of-the-art in-house facility equipped with fully automated filling and packaging lines.<\/span><\/p>\n<\/div>\n <\/span><\/span>Drafting, modification and updating of the technical documentation to obtain the CE mark, such as:<\/span><\/span><\/p>\n <\/span><\/span>Support to the drafting of the documentation required for the registration of medical devices into national and international markets.<\/span><\/span><\/p>\n<\/div>\n <\/span><\/span>Obtaining of the Free Sale Certificate for distribution in extra-UE countries.<\/span><\/span><\/p>\n<\/div>\n <\/span><\/span>Management of the relationships with Notified Bodies and with the italian competent Authority.<\/span><\/span><\/p>\n<\/div>\n <\/span><\/span>Conduction of pre and post-market clinical trials with the collaboration of CRO and external specialized centres.<\/span><\/span><\/p>\n<\/div>\n <\/span><\/span>Consulting service for the definition of texts and graphics on the secondary package (boxes and leaflets) and identification of the specific claims for the Medical Device.<\/span><\/span><\/p>\n<\/div>\n <\/span><\/span>Amendments, Technical File renewals and CE marking extensions following the registration phase of the medical device.<\/span><\/span><\/p>\n<\/div>\n The services we can offer for formulations study are:<\/p>\n<\/h2>\n <\/span><\/span>Contacts management, on behalf of customer, with external laboratories for the execution of some specific tests such as toxicological characterization, biocompatibility, primary packaging validation, test for contact lenses, ORAC test, aerosol solution nebulization test, chemical substances titration.<\/span><\/span><\/p>\n<\/div>\n![\"\"](\"\/cms\/wp-content\/uploads\/yootheme\/hero-shape-02.svg\")
<\/p>\nThanks to its in-depth regulatory knowledge and collaboration with specialised centres, Enable Innovations can coordinate the in vitro and in vivo testing phases.
In the field of medical devices, Enable Innovations can provide its partners with a “full service” starting from the customer’s idea, i.e. from lab-scale formulation to the manufacture of pilot batches and ending with the industrialisation of the product. It also provides regulatory support in the drafting of the Technical File and in obtaining the CE marking of class I, IIa and IIb medical devices.<\/h3>\nThe services we can offer regarding the regulatory field are:<\/h2>\n
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