A team that support all companies looking for a reliable partner in the design and production of medical devices.
Fabio Sanna
Founder & Extrusion Technical Manager
Roberta Bosio
Founder & Quality and Regulatory Affaire Manager
Alessio Ziletti
Founder & Quality EngineerFrom feasibility study to design, through prototyping and production up to validation for certification.
FARMEDICAL assists you at every stage, with competence and flexibility.
Discover why you should choose us.
Process knowledge
Ten years of experience in the field of extrusion and micro-extrusion for semi-finished products with external diameters starting from 0.40 mm.
Support
Help in choosing materials to use in projects. Continuous research and development to achieve the required performances.
Innovation
the best solutions are sought in compliance with the requirements dictated by the customer and in accordance with the regulations in force.
Reliable partner
Guaranteed transparency and quality processes at every stage, from design to after-sales.
Regulatory support
Many years of experience in quality management systems and regulations, with continuous training also for the customer.
Production capability
Development and production of extruded and assembled products to meet the different needs of medical partners.
Discover the products
Regulatory study
What we can do
for your business
- Drafting and maintenance of Technical Documentation for the Certification of Medical Devices according to Regulation (EU) 2017/745 and subsequent amendments and Regulation (EU) 2017/746 and subsequent amendments
- Development, updating and maintenance of the ISO 13485 Quality Management System and Integrated Systems
- We can support the customer in obtaining and maintaining the Certificate
- We support Medical Device Manufacturers, Medical Device Distributors and third-party companies to adapt and maintain their Quality Management System as required by the Industry Regulation
- Drafting and updating of Clinical Evaluations for Medical Devices and Post Market Documentation (CEP, CER, PMS, PMCF, PSUR, SSCP).
- Support for the definition of all tests to be carried out at external laboratories in order to comply with the Certification of your device.
- Drafting, updating and maintaining the risk analysis in accordance with ISO 14971
- We perform internal and supplier audits to comply with the regulatory requirements of the sector. We support the company during inspections by the Notified Body
Success stories
Many biomedical and pharmaceutical companies believe in us, discover some of the projects we are very proud of.
Do you need to design and validate a biomedical product?
Contact us and let's talkEvents and news
To the newsMedica 2024 Fair
We will be present as exhibitors at the MEDICA 2024 Fair, one of the most important international fairs dedicated to […]
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