ISO 13485 is applicable to the design and manufacture of medical devices. It is a mechanism to ensure that devices consistently meet the customer’s demands and all applicable regulatory requirements. ISO 13485 is the recognised standard with the primary objective of providing a framework to facilitate adherence to these as well as the harmonized international requirements.
Compliance with ISO 13485 is the initial phase in the compliance of the conformity of medical and in vitro diagnostic devices that must be assessed before the sale of the devices can commence.
Datalink offer a combined knowledge of regulatory requirements with a wide range of expertise in electronic product development to provide you with a medical product fully certified and fit for market taking into account the commercial realities. We provide integrated product development services from initial project objectives through to comprehensive support for product realisation. Our skills include concept evaluation, feasibility studies, project planning and management, design auditing, risk analysis, detailed design for manufacture, in-house manufacture (prototype to production volume), evaluation testing, design verification, design validation.
Design, development and manufacturing of medical devices are complex tasks requiring a comprehensive knowledge of engineering design and the related sciences and technologies. Certified to ISO 9001 and ISO 13485 quality management systems Datalink provide this wealth of experience and expertise. We provide adaptive customer support by offering flexible and comprehensive design and manufacturing services, whether fully in charge of the project or as part of a consortium for a multi-disciplinary project.
Our highly qualified team of engineers have many years of experience in the fields of medical imaging, urodynamic systems, transdermal drug delivery, digital technology for prosthetics, blood flow assessment, patient care and alarm monitoring and anaesthetic control and monitoring.
At Datalink we pride ourselves in an uncompromising approach towards ensuring the safety and performance in our customers´ products and systems.