Research & Development

In order to carry out its activities of R&D, prototyping and pilot batches preparation, Enable Innovations avails itself of a brand new production unit equipped with fully automated filling and packaging lines and laboratories complying with the most restrictive applicable regulations for medical devices production.

Thanks to the long experience and the technical background of the staff together with the cooperation with external specialized centers, Enable Innovations can coordinate the clinical trial procedure, through all the phases of in vitro and in vivo testing. Enable Innovations can also provide a “full service” package, starting from customers’ requests and ideas, preparation of lab-scale formulations, pilot batches and eventually product industrialization. We can also provide a regulatory support for Technical File drafting and CE marking for Medical devices in all classes.

The services we can offer in 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
- 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.
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.

The services we can offer for formulations study are:

Technical support for the formulation of new Medical Devices with the search of specific raw materials.
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.
Development and production of food supplements and Foods for Special Medical Purpose (FSMP).
Development and production of veterinary Medical Devices with the search of specific raw materials.