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Quality:
ISO 13485 
and GMP

Avery Dennison Medical is committed to delivering products and services of the highest possible standards to satisfy or exceed customer requirements for quality, safety, reliability, and service. 

Overview of eIFUs

Quality is an integral part of everything we do. 

Our facility in Longford is ISO 13485 and GMP compliant. 

ISO 13485

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. For more information, visit iso.org.

Good Manufacturing Practice (GMP)

A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. For more information, visit ispe.org/gmp-resources.


Certificates

THT-CER-000008 Certificate of Registration OHSAS 18001:2007 EC Certificate Production Quality Assurance System: Certificate GB19/964485 EC Certificate Production Quality Assurance System: Certificate GB19/964486 Longford Certificate of Registration ISO 13485 & EN ISO 13485 GBL-MAN-000005 Quality Policy CE Certificate MDR UKCA Certificate Mentor, OH - Certificate of Registration ISO 9001

Note: The ISO 13485 certification for our facility located in Turnhout, Belgium has been discontinued. Our facility in Longford, Ireland remains ISO 13485 certified. As our Turnhout facility does not manufacture finished medical devices, ISO 13485 certification is no longer a regulatory requirement for our operations at this location. Please reach out to our team if you have any questions.

Supplying adhesive tapes for the wearables industry for over 45 years.

Since 1975, we have been innovating adhesive materials and helping advance the development of medical devices. Our applications and technologies are an integral part of products used daily in medical facilities around the world.

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