Research & Development
We turn the customer’s idea into a finished product
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.
The services we can offer regarding the regulatory field are:
Drafting, modification and updating of the technical documentation to obtain the CE mark, such as:
- Design Dossier.
- Technical files.
- Risks and benefits analysis and Risk management.
- Clinical Evaluation report.
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- PMS, PMCF and PSUR according to the Regulation 2017/745 (UE) provisions.
- Rationals of evaluation of the toxicological and biological characteristics identified by specific tests of device profiling (chemical characterization, biocompatibility, etc.).
Support to the drafting of the documentation required for the registration of medical devices into national and international markets.
Obtaining of the Free Sale Certificate for distribution in extra-UE countries.
Management of the relationships with Notified Bodies and with the italian competent Authority.
Conduction of pre and post-market clinical trials with the collaboration of CRO and external specialized centres.
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.
Amendments, Technical File renewals and CE marking extensions following the registration phase of the medical device.
The services we can offer for formulations study are:
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.
Technical support for the formulation of new Medical Devices with the search of specific raw materials.
Development and production of food supplements and foods for special medical purposes (AFMS).
Development and production of veterinary medical devices, including research into specific raw materials.
Thanks to a fully dedicated area, we can carry out accelerated and long-term ICH stability studies in-house to define the validity of the product.
