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ISO 13485 Medical device

Quality Management Systems are an essential requirement for Medical Device Manufacturers and provide evidence of ongoing product quality and regulatory compliance.

What is the ISO 13485 standard? 

ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry.
It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices.  

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability. Organizations certified to ISO 13485 can not claim conformity to ISO 9001

In 2017 Taroni foundry has obtained the certification of compliance with ISO 13485 on Quality Management Systems for Medical Device.

DOWNLOAD CERTIFICATE ISO 13485

Connection with national requirements for approval of medical devices 

Legal access to markets for products is essential for manufacturers of medical devices. ISO 13485 is often required by national regulations as part of the approval process for medical devices, e.g. for the EU directive on medical devices (Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC, Active Implantable Medical Devices 90/385/EEC). 

MIDEST TAKES A NEW START IN 2018

This new edition, scheduled from Tuesday 27 to Friday 30 March, will be held in conjunction with INDUSTRIE Paris (the exhibition for production technologies and equipment), Smart Industries (the exhibition dedicated to the Industry of the Future) and Tolexpo (the trade show for sheet metal working equipments and solutions) at the Paris Nord Villepinte Exhibition Center.

This large gathering is now installed in 5 halls to give birth to a unique event of European dimension : GLOBAL INDUSTRIe
Through this strong initiative, the entire industrial ecosystem and the entire industrial value chain are valued.

THE WORLD’S LARGEST INDUSTRIAL SUBCONTRACTING NETWORK

MIDEST is the sole international show to specialize in industrial subcontracting.

VIST OFFICIAL WEBSITE
https://www.midest.com/en

Taroni Foundry go to EUGATEWAY TO KOREA

Taroni Foundry specialized in aluminium casting for medical devices participates at EU Gateway │Business Avenues

EU Gateway │Business Avenues is an initiative funded by the European Union helping European companies to establish long-lasting business collaborations in Asia.

Selected European companies meeting the eligibility criteria get the opportunity to participate in a one-week business mission focused on a specific sector in Korea, South East Asia, China and Japan. Companies benefit from a range of business support services, which include coaching, logistical, and financial support.

The Healthcare & Medical Technologies Sector covers a broad range of technologies, products, equipment and devises. Recent trends underline the principles of Circular Economy – reducing material inputs and resource intensity, greater durability or reusability of healthcare and medical devices.
Relevant sub-sectors include:

  • Assistive technologies: Homecare and rehabilitation equipment, to assist elderly people or people with reduced functionalities. Devices and prosthetics to assist or train elderly people or people with reduced functionalities.
  • Medical equipment: Any instrument, apparatus, device or material used in diagnosing, treating and/or preventing of human or animal diseases, thereby excluding the use of pharmacological, immunological or metabolic means.
  • ICT for health: New or improved equipment might be used for enhancing healthcare, such as miniaturised and cheaper electronics and sensors, high-density memory, micro-electromechanical systems, and novel combinations of existing devices.
  • Telemedicine and remote health monitoring: Homecare, telecommunication networks, radiographs, pathology freeze frames. Examination, observation and treatment of patients and the training of personnel by utilising telecommunications.
  • Nanotechnology healthcare
  • Life Science/ Biotechnology for health: Any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific use in healthcare; recombinant DNA, cell fusion, and new bioprocessing techniques to produce large molecules useful in treating and preventing disease.
  • Dental products: Diagnostic technologies, Preventive technologies, Oral hard tissue disease treatment technologies, Regenerative medical technologies, Dental laboratory technologies

www.eu-gateway.eu

logo-international-manufacturing-technology-show

IMTS 2016 - Sept. 12 - 17, 2016

The Americas’ Largest Manufacturing Show

The International Manufacturing Technology Show is one of the largest industrial trade shows in the world, featuring more than 2,000 exhibiting companies and 114,147 registrants. The event is held every two years in September at McCormick Place, Chicago.

For more info https://www.imts.com/

 

Also Fonderia Taroni USA was at RSNA 2017.
Thanks to people met there. Keep in touch !

The Radiological Society of North America (RSNA®) is an international society of radiologists, medical physicists and other medical professionals with more than 54,000 members from 136 countries across the globe. RSNA hosts the world’s premier radiology forum, drawing approximately 55,000 attendees annually to McCormick Place in Chicago, and publishes two top peer-reviewed journals: Radiology, the highest-impact scientific journal in the field, and RadioGraphics, the only journal dedicated to continuing education in radiology.

Through its educational resources, RSNA provides hundreds of thousands of continuing education credits toward physicians' maintenance of certification—more than one million CME certificates have been awarded since 2000. The Society also develops and offers informatics-based software solutions in support of a universal electronic health record, sponsors research to advance quantitative imaging biomarkers, and conducts outreach to enhance education in developing nations. Through its Research & Education (R&E) Foundation, RSNA provides millions of dollars in funding to young investigators, helping to build the future of the profession.

new-office-usaFonderia Taroni, to ensure its customers a service more accurate and timely assistance, has opened an office in Los Angeles USA
The staff is dedicated to customer support during pre and post sale, providing useful technical information in development of the project as well as rapid response and quick solutions to problems, guaranteeing an efficient level of support to the client.

Technical and Sales Office USA
5140 Greenbush ave Sherman Oaks
Los Angeles - CA 91423 USA

Andrea Ricci
Senior Sales USA
Phone:+1 (818) 404-2658

Email:This email address is being protected from spambots. You need JavaScript enabled to view it.

fus-pro-rapidThanks to rapid prototyping our customer was able to get the first samples in a single week. The fusion is made with alloy 42100 with T6 treatment.

 

 

 

Fusione in alluminio

Iran has always been a very attractive market for Italian industry. thanks to its growing commercial expansion Taroni foundry, light alloys gravity casting foundry, overlooking the Iranian market.

There have been several Iranian companies interested in light aluminum alloys casting made in Italy. The 40 years business know-how and continuous investment in technology make Foundry Taroni an attractive partner for the development of new projects and products.

simulazione di colata

 Especially Foundry Taroni and Alunetwork companies, of which he is the leader, will be key partners for the development of products in light aluminum alloys intended for the energy and rail freight sector, areas where Taroni Foundry has gained concrete experience bringing considerable advantages in terms of cost and time, to customers that in partnership they deliver new products.

Prototipazione rapida metallo

The containment of costs and time in the design phase of a new product is critical to the success of a project and for production; Foundry Taroni thanks to rapid prototyping services and casting simulation is indispensable supplier for companies intent on developing new products.

 

Fonderia Taroni has introduced a new production line of mergers in bronze alloys, running alongside the line production of light aluminum alloys castings.
Main alloys used are: Cu Al10 Fe4 and Cu Al10 Fe5 Ni5, but can also be used customized alloys upon customer request.
The main products manufactured are connector blocks for the railways and bushings up to 600 mm in diameter.

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Expertise and Technology foundry serving the health sector

foundry-aluminium-health-casting

Thanks to these two components that Taroni Foundry was established as a strategic supplier of aluminum castings for many companies in the biomedical field.
The skills developed over the years and the propensity to technological innovations have pushed Foundry Taroni to offer a complete service to manufacturers of machinery for the biomedical sector, in particular machines:
> X-rays
> Ultrasound
> MRI
> Radiotherapy

Foundry Taroni is able to interface with the customer's design and purchasing departments supporting them in the choice of aluminum alloys for use and development of the project due to casting simulations and rapid prototyping.
Casting simulations   and rapid prototyping are two basic services for the success of the project that bring significant benefits in terms of saving time and costs, thanks to the reduction in the time of sampling (1 weeks versus the standard 3) and the resolution of issues before the series production.

Contact ourThis email address is being protected from spambots. You need JavaScript enabled to view it.for advice

iso 512x244

Fonderia Taroni is always more sustainable: our company has obtained the Certification of Environmental Management System ISO 14001:2015 international standard for voluntary membership.
Another milestone in our journey of continuous improvement, we have chosen to take in recent years to offer customers and partners a further guarantee of quality, responsibility and proper environmental management of our productive activities.
The certification lasts three years, requires transparent commitments and provides for annual checks on the goals. It is in fact a real commitment to limit the impact of our processes, improve the reduction of emissions, implement environmental performance.
Here is another piece to add to the Qualifications Framework on the performance already achieved by our company, through which we pursue a sustainable development model.In fact, the environmental certification is in addition to Quality Management System, according to UNI EN ISO 9001:2015, and the entire organization is already aimed at achieving the next goal: the certification of the Quality Management System for Medical Devices in according to ISO 13485. a new milestone consistent with the vision of Fonderia Taroni.

Certificato ISO 14001:2015

foundry-aluminium-health-casting

Thanks to these two components that Taroni Foundry was established as a strategic supplier of aluminum castings for many companies in the biomedical field.
The skills developed over the years and the propensity to technological innovations have pushed Foundry Taroni to offer a complete service to manufacturers of machinery for the biomedical sector, in particular machines:
> X-rays
> Ultrasound
> MRI
> Radiotherapy

Taroni Foundry is able to interface with the customer's design and purchasing departments supporting them in the choice of aluminum alloys for use and development of the project due to casting simulations and rapid prototyping.
Casting simulations   and rapid prototyping are two basic services for the success of the project that bring significant benefits in terms of saving time and costs, thanks to the reduction in the time of sampling (1 weeks versus the standard 3) and the resolution of issues before the series production.

Contact ourThis email address is being protected from spambots. You need JavaScript enabled to view it.for advice

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