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). 

Save money in part price compare to sand casting.

Payback of tool in les then one year. Also with low volume.

200 pcs per year! Big burner more then 1 meter length !

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). 

Fonderia Taroni, with a view to the constant development of its medical division, offers investment steel casting certified according to ISO 13485.

As always, our priorities are 2:
speed and excellent quality/price ratio.

Taroni Foundry is able to support you in the development of new products from design to safety stock of the finished product
 

Investment steel casting for a wide range of medical devices:

• CT Scanner
• Blood pumps
• Dialysis instruments
• Cardiovascular devices
• Hospital Bed
• Mobile Cart
• Baby incubators
• Surgical lasers
• Trolley
• Opertaing tables
• Hospital furniture

Are you looking for a reliable partner for the development of your projects?

GET A QUOTE

Fonderia Taroni, with a view to the constant development of its medical division, offers investment steel casting certified according to ISO 13485.

As always, our priorities are 2:
speed and excellent quality/price ratio.

Taroni Foundry is able to support you in the development of new products from design to safety stock of the finished product
 

Investment steel casting for a wide range of medical devices:

• CT Scanner
• Blood pumps
• Dialysis instruments
• Cardiovascular devices
• Hospital Bed
• Mobile Cart
• Baby incubators
• Surgical lasers
• Trolley
• Opertaing tables
• Hospital furniture

Are you looking for a reliable partner for the development of your projects?

GET A QUOTE

Fonderia Taroni in un’ottica di costante sviluppo della propria medical divisios offre microfusioni in acciaio per dispositivi medici certificate in base alla norma ISO 13485

Come sempre le nostre priorità sono 2:velocità e ottimo rapporto qualità/prezzo

Le microfusioni in acciaio per dispositivi medici in acciaio per una vasta gamma di medical device:

Fonderia Taroni ti può seguire nello sviluppo di nuovi prodotti dalla progettazione al safety stock del prodotto finito

Microfusioni in acciaio per dispositivi medicper un'ampia gamma di dispositivi medici:

• Scanner CT
• Pompe di sangue
• Strumenti per dialisi
• Dispositivi cardiovascolari
• Letti d'ospedale
• Carrello mobile
• Incubatrici per neonati
• Laser chirurgici
• Carreli
• Tavoli operativi
• Mobili ospedalieri

CHIEDI UN PREVENTIVO

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