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Fonderia Taroni will be present as exhibitor at COMPAMED / MEDICA 2018- Düsseldorf, the branch of the medical subcontracting from 12 to 15 November 2018
For more information visit www.compamed-tradefair.com
 

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). 


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


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.


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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