Class I, IIA, IIB, and III medical devices. Our flagship.

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Production of class I, IIA, IIB, and III medical devices: putting health first.

Research applied to health leads to new ideas for people’s wellbeing, our speciality. Since 1983, we have been contract manufacturing all classes of medical devices, focusing on the innovative treatment of specific disorders.

Every one of our product is the result of research, high-quality consulting services, and the highest manufacturing standards. Safety and effectiveness are our driving forces.

A high purification process with residue levels under the detection limits of the analytical equipment.

High-quality incoming raw materials. We use only raw materials of the highest quality.

Hi-tech industrial process.

Checks and controls: we carry out analyses before, during and after production.

Zero endotoxins because we work in sterile conditions (white room).

The entire production process – design, data collection, packaging, marking, and release – is managed by our staff.

And thanks to our all-round support, the entire production process – design, data collection, packaging, marking, and release – is managed by our staff.

Our CE marked medical devices.

INTRA-ARTICULAR MEDICAL DEVICES

LINEAR HYALURONIC ACID

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CROSS-LINKED HYALURONIC ACID

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AESTHETIC MEDICAL DEVICES

POLYNUCLEOTIDES GEL

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CROSS-LINKED HYALURONIC ACID WITH BDDE

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LINEAR HYALURONIC ACID

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Placing products on the market IRA medical devices can be subject to the licence of the CE marked product or subsequent private label agreements with partner companies.

Quality in a test-tube.

We believe that there can be no compromise when it comes to quality, and we apply this principle to every stage of a project, from production, to testing and packaging. We monitor the entire production process in-house, we sample incoming materials, and we ensure that every formulation meets all conformity parameters.

OUR CERTIFICATIONS:
UNI EN ISO 9001:2015 since 1995 with certificate No. 423.
UNI CEI EN ISO 13485:2016 since 2008 with certificate No. 13790.
ISO 22716:2007 since 2013 with certificate No. 18549.
EFfCI GMP guide for Cosmetic Ingredients including the Certification Standard and Scheme for GMP for Cosmetic Ingredients – Revision 2017 since 2013 with certificate No. 18950.

Our technical support is at your service.

Our experts can help you develop your product, from its formulation to the finished product. We provide personalised and flexible consulting services to help you with the selection of raw materials and packaging, preliminary analyses, product certification, and regulatory matters. Contact us for more information.

full assistance

Need to analyse a product from scratch? Our laboratories are at your service.

Every new project is a challenge. Our team of experts is here to meet all your requirements and help you develop increasingly innovative solutions for an ever-changing market.

Research and development

Production of raw materials for pharmaceuticals and cosmetics.

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There’s a lot we can do together Get in touch. We’re at your service

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