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ANDROMEDA QUALITY ASSURANCE SERVICES
ABN 16 208 594 687
Andromeda
Quality Assurance Services is a registered business located in the Sydney
Metropolitan area of Australia. With over 18 years of Quality Assurance management
experience involving commercial and Defence Organizations, AQAS is well placed
to provide professional consultancy in the implementation and management of
Quality Management Systems.
AQAS has assisted electronic manufacturing, electrical/electronic suppliers and
medical device manufacturing Organizations achieve certification to ISO 9001,
'CE' Marking, EN46001, ISO13485 and the European Union Medical Device
Directives including uniform product recall procedures and vigilance systems
acceptable to the Notified Bodies within the European Community, add to this
the assistance provided for those companies needing to comply with FDA 21CFR820
and 510[k] submissions and AQAS can be seen to engage in the significant
compliance areas around the world
Certification has been awarded to our clients by such third part Organizations
as QAS (Australian Standards Association), DQAO (Australian Defence Quality
Assurance Organization), TUV (Germany, USA & Japan) and SGS - for
"CE" marking.
US
compliance to regulatory and quality requirements has been verified by FDA
investigators.
With the advent of electronic media and in particular, the internet, AQAS is
equipped to provide it's services throughout Australia
and overseas.
Quality Management Systems implemented:
ISO
9001-2000 Quality management systems - Requirements
ISO 13485-2003 Medical devices - Quality management systems
Product recall
Corrective & Preventive Actions system
Regulatory System and processes implemented - Europe:
CE
Marking, FDA [510k],
Medical Device Directives
Risk management file,
Technical Files,
Vigilance system
Regulatory System and processes implemented - United States:
21CFR820
Quality Regulation
Device History Record
Design History File
Quality System Record
Removals & Modifications
Device Master record
Regulatory System and processes implemented - Canada:
Canadian
Medical Devices Regulation (for CMDCAS)
Services include:
* Systems Implementation,
* Documentation creation,
* Internal Quality Audits (Lloyds certified),
* Training,
* Interfacing with NB's for CE Marking and harmonized standards certification,
* Out-sourcing,
* Foreign company Sponsorship to the TGA
We look forward to helping you in your Quality Assurance and Regulatory
requirements
Our contact details are:
Mobile: 0414 662 566
E-mail: sales@aqas.com.au
Fax: +61 2 9625 4360
DISCLAIMER
The information on this web site is provided in good faith and was current at
the time of preparation, however circumstances may have changed.