certifications
YOUR OVERVIEW OF OUR CERTIFICATIONS
In the below we have listed our certifcations and the standards we adhere to. Please follow the below anchorlinks to the certificate or standrd of your interest.
If you can't find what you're looking for, please don't hesitate to contact us
ce
Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
For more information about the regulation, please follow this link
fda
The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.
To find our specific approval, please go to this page
To learn more about the FDA approval process, please visit the FDA website here
ISO 13485
ISO 13485:2016 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 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
For more information regarding ISO 13485 , please go to the ISO website
Downlod our certificate
ISO 9001
ISO 9001 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in ISO’s quality management principles. Using ISO 9001 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits.
For more information, please go go to the ISO website
Download our certificate
ISO 14001
ISO 14001 sets out the criteria for an environmental management system and can be certified to. It maps out a framework that a company or organization can follow to set up an effective environmental management system. Designed for any type of organization, regardless of its activity or sector, it can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.
For more information, please go to the ISO website
Download our certificate
MDR
This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union.
This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.
For more information regarding the MDR Regulation, please click here
FSC MIX
The FSC MIX standard is applied to our packaging material. Products that bear this label are made using a mixture of materials from FSC-certified forests, recycled materials, and/or FSC controlled wood. While controlled wood is not from FSC certified forests, it mitigates the risk of the material originating from unacceptable sources.
For more information regarding the FSC standards, please click here
OEKO-TEX®
OEKO-TEX® consists of 18 independent institutes in Europe and Japan. Together the institutes are continuously developing test methods and limit values for the textile and leather industry, we provide important boosts for innovation and thus make a significant contribution to the development of high-quality products. Our mission is to create trust in textiles and leather and in their production. With our portfolio of services and certificates, we support you on your path to a sustainable future and offer customised solutions.
To find out more about OEKO-TEX®, please click here
Download our certificate
REACH
REACH (EC 1907/2006) aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. This is done by the four processes of REACH, namely the registration, evaluation, authorisation and restriction of chemicals. REACH also aims to enhance innovation and competitiveness of the EU chemicals industry.
For more information regarding the REACH Regulation, please visit the website
DISCOVER MORE
PRODUCTS
Dive into our wide range of products across our four brands. Use the seamless filtering function to find your therapeutic area of interest.
GO TO PRODUCTS
R&D
Get an in-depth insight into how we work with product development, innovative collaborations and the newest technology.
GO TO R&D
ABOUT US
Get to know us. Learn about our history, our organisational set-up, and your career opportunities with us.
GO TO ABOUT US
SIGN UP TO OUR NEWSLETTER
Want to stay up to date with the news from the world of medical garments and textiles and learn about the latest developments with the Tytex brands? Subscribe to our corporate newsletter:
“Better healthcare together”.
