FAQ
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) and the Australian Therapeutic Goods Administration (TGA).
ResMed’s quality system is also based on the requirements of:
- ISO 13485
USA FDA 21 CFR Part 820
REACH
RoHS
Health Canada declarations
European Medical Device Directive (MDD) – phthalate labelling
Other region specific requirements
ISO 14001
To enable ResMed to comply with these requirements, as a minimum, our suppliers must have a Quality Managment System in place, for example, certified to ISO13485 or another suitable industry standard.
What are the first steps of becoming a ResMed supplier?
