https://www.avient.com/sites/default/files/2022-05/DOC 1879.pdf
Is Avient experienced in exporting
and importing within the United
States?
This document is property of Avient
Corporation and may not be reproduced or communicated to third parties without authorization.
8.0 Technology
Is there a review program to
control and assure proper
development of products from the
research state through
production?
Yes, through 3rd party pest control and according to
GMP practices (as required).
10.3 Control of Monitoring and Measuring Devices
Do test methods have documented
calibration/standardization procedures for
equipment, instrumentation, and measuring
devices?
https://www.avient.com/sites/default/files/2022-06/Malmoe 308840_en_13485_22.pdf
Avient Colorants Sweden AB
Järnyxegatan 7
Box 9053
200 39 Malmö
Sweden
Scope
Avient CAI
Design and manufacture of colour and additive
concentrates and specialty compounds for
the Healthcare and Medical device market.
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 37081 Validity 01.03.2022 – 28.02.2025
Issue 01.03.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
https://www.avient.com/sites/default/files/2024-08/Versollan TPE-Compression Controller - Case study snapshot.pdf
AVIENT SOLUTION
MEDICAL DEVICE
MANUFACTURER
C O M P R E S S I O N C O N T R O L L E R
H O U S I N G G R I P
• Good adhesion to PCTG
• Comfortable grip combined with ergonomics
• Medical regulation compliance
• Provided a medical-grade TPE with excellent
bonding to PCTG and good chemical resistance
• Improved ergonomics and aesthetics with a soft-
touch material
• Met medical regulation compliance: FDA21 CFR
177.2600
• Delivered good colorability to ensure a stable
esthetic
KEY REQUIREMENTS
OVERMOLDING + REGULATORY SUPPORT
LEARN MORE
Versollan Thermoplastic Elastomers
Copyright © 2024, Avient Corporation.
https://www.avient.com/products/thermoplastic-elastomers/versollan-thermoplastic-elastomers
Slide 1: Medical Device manufacturer
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/remafin-concentrates-polyolefins
Our diagnostic experts can help with analysis and testing related to early stage development for medical devices
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Avient’s portfolio enables 5G technology from a range of fiber optic cable components to antennae and base station materials, as well as 5G-enabled devices.
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Caption: New UL certification for Bergamid™ high-performance solutions helps manufacturers meet global standards for outdoor electrical devices.
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Managing heat in molded interconnect devices with specialty thermoplastics
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Overmolding these materials on the outside of your device can add impact protection, abrasion resistance, and UV resistance properties depending on the intended use environment of the speaker.
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We offer floral and fruit scents for a number of applications including personal care packaging, wearable electronics devices, and even sporting goods.In addition to attractive fragrances, we can also provide scents that repel small animals and insects to protect wire and cable from damage.
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/renol-concentrates-non-olefins
Our diagnostic experts can help with analysis and testing related to early stage development for medical devices