What sorts of components and services does ResMed need?
Because ResMed is an innovative medical device manufacturer we are always interested in identifying new technologies and developments including plastic injection mouldings, textiles, printing and packaging, elastomers, electronic componentry, mechanical fasteners, tubing and a broad range of services.
Where are your manufacturing facilities?
ResMed is a global medical device manufacturer with manufacturing operations in:
What regulatory requirements do I need to comply with?
As a leader in developing and manufacturing medical devices, ResMed must meet stringent audit requirements of international regulatory bodies, such as the US Food & Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and ISO 9000 quality systems.
ResMed’s quality system is also based on the requirements of:
USA FDA 21 CFR Part 820
Health Canada declarations
European Medical Device Directive (MDD) – phthalate labelling
To enable ResMed to comply with these requirements, as a minimum, our suppliers must comply with the requirements of ISO9001.
What are the first steps of becoming a ResMed supplier?