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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:

  • Australia and Asia Pacific

  • North America

  • Europe

 

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:

  • ISO 14001

  • ISO 13485

  • USA FDA 21 CFR Part 820

  • REACH

  • RoHS

  • 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?

We want to make the process of becoming a supplier as smooth as possible, please refer to the Supplier Induction information. 

 Contact Us

ResMed Global Supplier Alliance (GSA)

  • 1 Elizabeth Macarthur Drive, Bella Vista
  • Sydney, Australia.


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