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WE ARE NOW ISO 13485 REGISTERED!

Applied Plastics achieves ISO 13485:2016 certification

NORWOOD, MA –– Applied Plastics LLC, a portfolio company of Vance Street Capital and a leading provider of PTFE coated mandrels, fine wire and metal tubing, announced today that the company is now certified to ISO13485:2016 for Medical Device and Quality Management Systems by National Quality Assurance, USA.

ISO 13485:2016 is internationally recognized and specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that meet customer and applicable regulatory requirements.

“We are very proud of this certification and it demonstrates the commitment of our team to consistently meet our customer’s quality needs. ISO 13485 certification is an excellent achievement and another significant milestone in our commitment to be the preferred PTFE coating supplier to the medical device market.” said Tom Barrett, CEO.

“Our foundation has focused on manufacturing PTFE Natural® coated products and components that meet or exceed industry standards. Achieving ISO 13485 certification demonstrates the importance Applied Plastics places on our commitment to meeting customer satisfaction and global regulatory requirements,” stated Ed Perry, Director of Quality & Regulatory.

About Applied Plastics – founded in 1953, Applied Plastics serves customers worldwide in the medical device industry with their trademarked PTFE Natural® coating which is applied to a variety of metals, including stainless steel, nitinol and silver-plated copper. Applications of use include mandrels, pull wires, core wires, hypotubes, stylets and guidewires Applied Plastics supplies PTFE coated mandrels, fine wire and hypotubes to customers globally ranging from large OEMs and contract manufacturers to R&D startups. Their coated products are widely used in high-growth microcatheter segments such as cardiovascular, electrophysiology (EP), neurovascular, peripheral vascular and structural heart. For more information, visit appliedplastics.com.

Contact:
Jeri Lynne Swamp, Digital Marketing Manager
P: 860-331-9935
E: [email protected]

 

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Superior medical devices require superior coatings.

Our proprietary PTFE Natural® coated mandrels offer unmatched benefits.

low-co-friction

Low Coefficient of Friction

PTFE Natural® coatings provide a coefficient of friction generally in the range of 0.05 to 0.20, depending on the load and sliding speed.

heat-resistance

HEAT-RESISTANCE

PTFE Natural® coatings can operate continuously at temperatures up to 550°F and can be used for intermittent service up to 600°F with adequate ventilation.

non-stick

Non-Stick

Non-Stick Very few solid substances will permanently adhere to a PTFE Natural® coating. While tacky materials may show some adhesion, almost all substances release easily.

chemical-resistance

CHEMICAL RESISTANCE

Chemical environments usually do not affect a PTFE Natural® coating. Only molten alkali metals and highly reactive fluorinating agents are known to affect this coating.

robust-coating

ROBUST COATING

The proprietary PTFE Natural™ coating process enhances the substrate bonding surface to provide optimum lubricity without flaking or cracking.

non-wetting

NON-WETTING

Since PTFE Natural® finishes are both hydrophobic and oleophobic, cleanup is easier and more thorough.