advan

A NEW PROJECT…BASED ON 20 YEARS OF EXPERIENCE!

Production

Design and production are carried out by highly trained and specialized personnel with the aim of guaranteeing an entirely controlled production chain, synonymous with quality and precision.

R&D and design

Advan can manage the entire development process of a medical product, from its concept to its development, from product engineering to its certification and its series production.

Quality and certifications

Plan1Health is certified according to the international standard EN ISO 13485:2003. The industrial sector of implantable drug delivery systems certifies that our quality system and our productive chain are compliant with Class III product requirements, thus being compliant with a higher standard than the one required for dental implant devices.

Materials

All materials used to manufacture any component are expressly intended for medical use and are compliant with ASTM standards (American Society for Testing and Materials).

We develop, manufacture and sell medical devices – among them systems for dental implantology and drug delivery systems – that can be implanted for a long-term period in the human body and are sold both in Italy and abroad. We provide companies and professionals, willing to pursue innovative projects, with the necessary know-how and resources to implement them, assisting them from the project development and business plan to the manufacturing process.

The place of business (commercial and administrative headquarters) features the warehouses for finished and semi-finished products, an 80 m2 ISO class 7 clean room, a laboratory for surface washing and treatment and a production area devoted to quality control, assembly, packaging and labelling. On the other hand, the manufacturing plant is a separate unit: it was specifically planned and built in such a way that the flow of materials is streamlined for medical products – some of them sterile – during the whole production process.

We can manage the entire development process of a medical product, from its concept to its development, from product engineering to its certification and its series production. The whole project development is carried out in line with international standards, in particular with ISO 13485 and MDD 93/42. Thanks to the gained competence and experience, Advan is constantly available to transform emerging clinical needs into reliable industrial medical products, suitable to be launched on the market.

We are compliant with the international standard EN ISO 13485:2003 and we operate according to the Legislative Decree no. 46 dated 24 February 1997 (implementing the European Directive EU MDD no. 93/42/EEC). We hold a quality management system certification in the medical field: this means that our products and services are compliant with current laws and regulations, thanks to the adoption of tested, controlled and constantly improved organisational models. All medical devices, placed on the market, bear the CE marking: this proves that our products meet all requirements foreseen by Directive 93/42/EEC regarding, for example, safety, the choice of materials and biocompatibility. With its research and development activity and its high-quality service, Plan1Health wants to be close to its clients and to listen to their needs and transform such needs into devices and solutions that fulfil the desire for improved health and wellbeing expressed by patients.