As the manufacturer of the KUDUwave portable audiometer we are thrilled that we have just received the fresh new copy of our ISO 13485; 2016 certificate, and updated, migrated EC certificate.
Why is ISO 13485 so important to us?
It is an internationally recognized quality standard which sets out the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices throughout the world.
Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations, and responsibilities, as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485:2016 is the latest version of ISO 13485, and eMoyo is one of the first medical device manufacturers in South Africa to adopt and to be certified to this standard.
ISO 13485 is based on eight quality management principles: customer focus, leadership, the involvement of people, process approach, system approach to management, continual improvement, fact-based decision-making and mutually beneficial supplier relationships.
The key to this standard is a quality management system that builds the themes of the standard into its processes from the very beginning. As a result, we, as a medical device manufacturer, can realise better product quality, cost-effectiveness and quicker time to market.
The bottom line?
ISO 13485: 2016 is a tool that reassures consumers that any risk to them with regards to the use of medical devices, is minimised through a quality management process. Thus ensuring that products, like the KUDUwave, are safe for use.
The FDA will soon be adopting ISO 13485 as the only Quality Management System for medical device manufacturers in the USA.
What then is an EC Certificate?
This certificate allows us, as a manufacturer, to place the CE mark on our audiometers. This is a major requirement for medical device entry into just about every country.
In fact it is a strict requirement in order to qualify for a Department of Radiation Control license. This a license required for all audiometers that are sold in South Africa. The EC certificate is also an essential requirement to distribute a medical device in the European market.
This certificate can only be issued by a Notified Body, this, after stringent reviews of our technical files and audits of our Quality Management System at eMoyo which is ISO 13485.
Our Notified Body, BSI-UK, The British Standards Institute, is one of only a handful of notified bodies that can issue EC Certificates for medical devices. Additionally, BSI-UK is the first, notified body to be designated under Europe's new Medical Device Regulation (MDR).
The uncertainty regarding the impact which Brexit will have on medical devices has prompted BSI to form a registered notified body in the Netherlands, BSI-NL, as well as retaining the original BSI-UK, Another world first.
We, at eMoyo, have migrated our EC Certificate to BSI-NL, thereby avoiding any obstacles we may encounter getting our device into Europe post-Brexit. eMoyo is again leading the way as one of the first medical device manufacturers to take advantage of this migration.
So there you have it, eMoyo with it’s world-class 13485:2016 certification and the EC certificate for the design, development and manufacture of portable audiometers will continue to ensure quality, reliability of KUDUwave Audiometers and ensure that they are available worldwide.