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- Medical regulatory consultancy
For anyone seeking medical regulatory advice with regard to TGA
or FDA compliance or who is considering launching a new medical
device or pharmaceutical Anne's assistance can be invaluable.
Anne works seamlessly with an organization’s internal development
teams to deliver results on time and above expectations. As CEO
of Ausonex, I engaged Anne to support our business in developing
a new medical device and commend her contribution. May 5, 2010
Top qualities: Personable, Expert, High Integrity
Geoffrey Wanless hired Anne in 2008.
- Regulatory Affairs and ISO 13485 expert
Anne is a knowledgeable regulatory affairs person who also is
an expert in ISO 13485. These two combine to make her very desirable
when it comes to working with both Australian and overseas manufacturers
and distributors. May 9, 2010
Top qualities: Great Results, Expert, High Integrity
Barry Evers-Buckland hired Anne in 2009, and hired him/her
more than once.
- Consultant
Anne is very good at her consultancy work and always supplies
the company with the correct information in a timely manner; I
would highly recommend her to anyone looking to engage a regulatory
consultant. May 5, 2010
Top qualities: Great Results, Expert, High Integrity
David Thomas hired Anne in 2006.
- Regulatory & Quality Compliance
Anne is a detail-oriented manager who has significant experience
in developing and implementing Quality Systems, she works well
with our clients training and promoting discussion in order to
expand their understanding of the device requirements. Anne is
patient and provides ideas to help in problem resolution. Anne
also undertakes regulatory activities such as device registration
and delivers good outcomes. April 28, 2010
Top qualities: Expert, Good Value, High Integrity
Christine CUTHBERTSON hired Anne in 2009, and hired him/her more
than once.
- Quality and Regulatory Officer at Ausonex Pty Ltd
Anne helped guide Ausonex through the ISO 13485 documentation,
FDA regulations and risk analyses. Anne is highly experienced
in the manufacturing and wet sciences area, and was capable of
readily applying her knowledge and experience to the areas of
hardware and software design for medical devices. April 28, 2010
Andrew Bradley (Chief Technology Officer at Ausonex) managed Anne
at Ausonex Pty Ltd.
- Regulatory project management for medical device
Anne looked after a tricky transition registration for one of
our medical devices. She was happy to resolve each hurdle and
kept me informed all the way. It was a pleasure to have someone
take ownership and see the project through to the end, especially
since I was busy with other projects. May 5, 2010
Top qualities: Great Results, Expert, On Time
Sian Stubbs hired Anne in 2007.
Let Acrapack assist you with your
quality system development or regulatory activities
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