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 visit:
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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 go to this page
To learn more about the FDA approval process visit the FDA's website here
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 go to ISO.ORG
Download our ISO 13485-certificate here
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 regarding ISO 9001 go to ISO.ORG
Download our ISO 9001-certificate here
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 regarding ISO 14001 go to ISO.ORG
Download our ISO 14001-certificate here
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 visit https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05
The FSC MIX standard are what 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 visit FSC.ORG/EN
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® go to oeko-tec.com/en
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 visit ec.europa.eu
Sedex is a membership organisation that provides one of the world’s leading online platforms for companies to manage and improve working conditions in global supply chains. Sedex provides practical tools, services and a community network to help companies improve their responsible and sustainable business practices, and source responsibly.
For more information regarding Sedex go to sedex.com
Download 2019 SMETA Audit Report - summery
The main purpose of the SFDA establishment is to regulate, oversee, and control food, drug, medical devices, as well as to set mandatory standard specifications thereof, whether they are imported or locally manufactured. The control and/or testing activities can be conducted in the SFDA or other agency's laboratories. Moreover, the SFDA is in charge of consumers awareness on all matters related to food, drug and medical devices and all other products and supplies.
For more information regarding SFDA go to sfda.gov.sa/en