ISO 13485 is now the Management System that forms the foundation of regulatory compliance in countries around the world and is the only internationally recognised standard focused solely on Medical Devices.
Why ISO 13485
ISO 13495 provides a framework for monitoring and measuring process performance and operations related to the design, manufacture and distribution of Medical Devices ensuring increased efficiency and improved customer satisfaction. It also ensures that you focus on the specific regulatory requirements associated with Medical Devices to support conformance with National Medical Device Directives.
Benefits to your client.
Your customers can purchase your Medical Devices and Services in the knowledge that you have the capability to provide product and services of a consistent quality and comply with the related local and international regulatory requirements.
Why use AJA Registrars?
AJA Registrars is accredited for most types of device from Non-Active, Non-Implantable devices through to In Vitro Diagnostic Medical Devices and have experience and knowledge of the regulatory requirements throughout Europe and the rest of the world.