Acrapack Regulatory Consultants

Acrapack can assist with providing solutions to your compliance challenges

Acrapack Regulatory Consulting – How We Can Help

With the experience and expertise you need to meet your regulatory requirements.
We can help unravel your registration compliance and quality problems, by understanding your product to market goals and to help bring your dream to life.

Providing you

  • Solutions to your compliance challenges
  • Experience to complete your registration projects within agreed time frames and costs
  • The right advice to ensure your Healthcare products are marketed in compliance with Medical Device and IVD regulations for the Australian market and for international markets.
  • Post market regulatory support to ensure the requirements for each of your markets is maintained to meet regulatory compliance.
  • Practical implementation methods for developing and adjusting your company’s Quality Management System in accordance with ISO13485 and the FDA’s 21 QSR 820 to meet your business requirements
  • Support for your company to ensure compliance to the international requirements of US FDA Quality Management System Regulations (QMSR); ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes and MDSAP [Medical Device Single Audit Program]; European Regulations for Medical Device [MDR] or In Vitro Diagnostic [IVDR]

“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.

Jeannie Devereaux
Vice President at Emcyte Pty Ltd

Visit Linked In Find out more about Anne Frances Jones and connect on LinkedIn

If you are an overseas company with no physical location in Australia or New Zealand, you will need an Australian sponsor or New Zealand sponsor or both for compliance to the regulations and for the registration processes in both countries. We offer Australian sponsor and New Zealand sponsor services under ACRA Regulatory Services.

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

Call Acrapack today on +61 400 284 808.

Contact Acrapack

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