Medical device design is not just about the designing of the product itself, but critical understanding of the processes and requirements to suit the global directive of ISO13485 in each class.
4design has a team of professionals who can guide you through the development of a Quality Management System essential to a medically compliant product. Our partners can help guide you through clinical trials or submissions to the TGA (Therapeutic Goods Association) to ensure the product can navigate these standards in a cost effective and timely manner.
We’ve developed products for some of the industry leading medical device companies in this sector including Resmed, Nanosonics, AtCor Medical, Dynamic Controls, Invacare, Polartechnics and Headsafe to name a few.
Our professional team of product designers have worked on a broad range of complex medical products which involve the latest innovative and ground breaking medical technology. Our comprehensive solution covers all aspects of industrial design, engineering and manufacture whilst incorporating all your regulatory requirements.
Regulatory planning and compliance presents unique challenges to the design and development of medical devices. With our in-depth knowledge of local and global regulatory requirements of the TGA and FDA, we can guide you through the challenges and minimise risks early in the design process.
We can assist with the documentation required for regulatory submissions and create the collateral required for clinical trials.
With years of production and manufacturing experience we have global organisations that specialise in the manufacture of medical devices for the supply of parts, components and finished assemblies. We can help you with the implementation of a range of different production processes and techniques to comply with the medical device directives.
We supply many medical products both locally and offshore with auto-claving facilities for sterilisation, clean room assembly, liquid silicon injection and several highly specialised production capabilities.
Our knowledge and experience are second to none and our partners are highly qualified to assist in development of any medical or wellness device.