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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
Q-Pulse Document Management System
AQAS maintains a business partnership with Gael Ltd for the express
purpose of selling their "Q-Pulse" Document management System software.
Q-Pulse software is both affordable and easy-to-use.
Low Cost of Ownership
To find out more about this software go to
www.gaelquality.com
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.