Spiros Medical Sheet 2015 TM

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A PART OF YOUR PRODUCT. A PARTNER IN YOUR SUCCESS. Your Partner for Medical Springs and Wireforms Spiros is a leader in the medical industry through continued investments in employee training, the latest machinery, materials supply chain and our lean manufacturing processes. As a medical component partner, we extend our capacity to deliver precision, quality wire products and assemblies. Our highly-specialized and knowledgeable teams are prepared for first sample runs, prototypes, speed to market and tight launch deadlines. We work side by side with our customers to meet their requirements, ranging from a single portion of the process to utilization of our entire set of solutions. From design review to manufacturing to final delivery, we channel all our innovation strength, expertise, and resources to our customers. Medical Certifications Our commitment to world class quality ensures that our products and services meet or exceed the highest standards set by all U.S. and internationally recognized agencies. Spiros Medical is established as an industry-wide, award- winning supplier with high quality standards through medical certifications and continued enforcement of inspection requirements. Key certifications include: Component and Device Capabilities Custom Wire Coiling Reinforced Coils Compression Springs Torsion Springs Extension Springs Guidewire Manufacturing Fine Wire Coiling Continuous Coils Introducers Cannulas Wires Pigtail Mandrel Wire Assembly ISO 13485:2003 Represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996). ISO/TS 16949:2009 An ISO technical specification aimed at the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. It is based on the ISO 9001 standard and the first edition was published in June 1999 as ISO/TS 16949:1999. ISO 9001:2008 ISO 9001 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today. Medical Capabilities

Transcript of Spiros Medical Sheet 2015 TM

Page 1: Spiros Medical Sheet 2015 TM

A PART OF YOUR PRODUCT.

A PARTNER IN YOUR SUCCESS.

Your Partner for Medical Springs and WireformsSpiros is a leader in the medical industry through continued investments in employee training, the latest machinery, materials supply chain and our lean manufacturing processes. As a medical component partner, we extend our capacity to deliver precision, quality wire products and assemblies.Our highly-specialized and knowledgeable teams are prepared for first sample runs, prototypes, speed to market and tight launch deadlines. We work side by side with our customers to meet their requirements, ranging from a single portion of the process to utilization of our entire set of solutions. From design review to manufacturing to final delivery, we channel all our innovation strength, expertise, and resources to our customers.

Medical CertificationsOur commitment to world class quality ensures that our products and services meet or exceed the highest standards set by all U.S. and internationally recognized agencies. Spiros Medical is established as an industry-wide, award-winning supplier with high quality standards through medical certifications and continued enforcement of inspection requirements. Key certifications include:

Component and Device Capabilities

• Custom Wire Coiling • Reinforced Coils

• Compression Springs • Torsion Springs

• Extension Springs • Guidewire Manufacturing

• Fine Wire Coiling • Continuous Coils

• Introducers • Cannulas Wires

• Pigtail Mandrel • Wire Assembly

• ISO 13485:2003 Represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

• ISO/TS 16949:2009An ISO technical specification aimed at the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. It is based on the ISO 9001 standard and the first edition was published in June 1999 as ISO/TS 16949:1999.

• ISO 9001:2008ISO 9001 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based. Over one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today.

Medical Capabilities

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7666 HWY WW WEST BEND, WISCONSIN 53090 | 800.972.8232www.spirosind.com | www.springmanufacturingcompany.com

Medical GuidewiresDevices used to enter tight spaces, e.g., obstructed areas or channels. Guidewires vary in size, length, stiffness, composition, and shape of the tip. A wire or spring used as a guide for placement of a larger device. Spiros Medical currently manufactures these types of guidewires:

Medical WireformsSpiros Medical produces medical wire forms that are critical to the success of today’s evolving medical technologies. We can custom fabricate a wide range of simple or complex medical wire forms from various materials to suit your specific needs. Our engineering specialists are ready to assist you through every phase of your wire for components.

• Standard, Fixed Core and Special Products.• .014” through .150” in diameter• Lengths up to 510 cm• Flexible Tips• 3 cm to 4 cm with smooth transition to full body stiffness standard. (Special tips also available.)• J Tips (3 mm J standard, also available 1 mm through 15 mm)• Depth Marks / Laser Marks• Standard and Custom available• Materials available include 304 V stainless steel, nitinol and a variety of other materials available• PTFE Coatings

Reinforced CannulasA cannula is a tube often used for the delivery or removal of fluid or for the gathering of data. Cannula Springs are mainly used to reinforce tubing and stabilize the wall during the application of a vacuum.

Device Contract AssemblySpiros Industries is your single source contract assembly partner for wire component manufacturing. We use integrated and advanced technologies to take your wireform assembly to a finished product. Let the Spiros team leverage our medical partners to help you achieve the speed to market finished product you are looking for. As your single, turn-key wire assembly partner for medical device wireforms we understand the real depth of your requirements!

For more information contact Thomas McAdams: 262.323.4260 • [email protected]