Expertise and Professionalism at the Service of Our Partners
The experience of our Development Team guides and supports you throughout the process of developing your medical device.
For over 30 years, we have assisted leading national and international players in the development of dental implant surfaces, enabling them to compete with the most prominent names on the global stage.
Our highly flexible automated process allows us to support the development of any type of implant without compromising quality or precision.
Our deep understanding of the dental market enables us to provide expert advice and assistance at every stage of the development process, from surface engineering to final packaging.
We work in partnership with leading sterilisation companies. Following packaging in our ISO Class 7 cleanroom, we take care of sending your medical devices for sterilisation and then deliver them to you, ready for market release.
Our analytical laboratories, in addition to supplying the data required for the preparation of your Technical Dossier, provide a robust scientific foundation, ensuring a competitive edge over major market players.
How Our Team Can Support Your Development:
1 – Initial Consultation
Our team of experts will arrange an initial meeting with the client to present the advantages of Nobil Bio Ricerche surfaces, why they matter, and how they deliver excellence to professionals and patients alike, with millions of documented case studies. We listen carefully to the client’s objectives, targetmarkets, and desired device specifications to define the technical characteristics of the ideal medical device.
2 – Process Development
Based on the defined technical specifications, we create a detailed development plan outlining the features of the medical device. During this stage, our experts optimise the client’s requirements where needed, ensuring the highest standards of excellence in the sector.
3 – Prototyping
An initial small-scale prototype production run is developed to fine-tune our process and provide the client with a tangible example of what was agreed during the development phase. At this stage, any modifications and improvements can be implemented. Process and quality control procedures are also defined at this stage to ensure absolute precision for the client.
4 – Technical Dossier
Our quality and regulatory experts provide all the documentation required for the client to prepare the Technical Dossier of the medical device efficiently and within the shortest time possible. Samples needed for sterility and bioburden testing, along with all other materials required to demonstrate device safety, are supplied to the client, who also receives support throughout the certification process.
Our assistance continues beyond completion, during follow-up audits, our staff remain available to provide any materials required by the notified body.
5 – Serial Production
Based on the developed technical specifications and after finalising the client-specific production and control procedures, we begin the first stage of full-scale manufacturing.
Precision and passion form the foundations of a solid and lasting partnership.
If you are ready to start developing your next medical device, contact us today.
