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Acrapack Regulatory Consultants

acrapack regulatory consultancy recommendations

We are committed to supporting our clients in the medical, biotechnology, lifescience and healthcare industries maintaining high standards and providing complete solutions for Quality, Regulatory and Compliance challenges.
See what our clients have to say.

Registration of IVD Medical Devices to meet new legislation

Anne has provided a detailed and informative review of our document requirements in preparation for the transitioning of registering our IVD Medical Devices to meet the new legislation. Her guidance with the format for the STED and Clinical Evidence helped us to set up our templates and ensure that we covered all aspects of the documentation. It has been priceless to have an independent reviewer. Many thanks for her kind assistance.
August 19, 2014

Top qualities: Expert, Good Value, High Integrity
Carolyn Sloman

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“the most efficient TGA consultant I have dealt with”

I employed Anne’s services for a new medical device company in Australia. Anne was the most efficient TGA consultant I have dealt with. Anne has been recommended to my colleagues.
Jul 7, 2015

Jeannie Devereaux
Dermal Regenerative Therapy

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“I will be hiring Anne again for future projects”

I have worked with Anne on many occasions and will be hiring her again for future projects.
September 26, 2014

Shawn Simmons

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If you are an overseas company with no physical location in Australia, you will need an Australia sponsor for compliance to the regulations and for the registration process. We offer an Australian sponsor service under ACRA Regulatory Services.

Contact us to start the process and register your medical device.

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Regulatory Affairs and ISO 13485 expert

“Anne is prompt and efficient in all aspects of the work that she carries out for our medical company in regards to our regulatory requirements with the TGA. She demonstrates an in depth knowledge of the processes and requirements. We look forward to continuing our solid relationship.”
August 20, 2014

Top qualities: Expert, Good Value, On Time
Robert Yee

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ACRA regulatory services as your Australian sponsor

Acting on your behalf as to register your medical device by communicating with the Therapeutic Goods Administration (TGA) and carrying out obligations placed on the Australian sponsor in relation to medical device or IVD device registrations, in order to meet and show compliance with the Australian Therapeutic Goods requirements.

Find out more about how we can assist as your Australian sponsor

Let Anne and Acrapack assist you with your regulatory and quality challenges, or with your quality management system development.

> Find out how Acrapack can help you

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