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.
- 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 to international regulations
- 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 System (QS) Regulations / Medical Device Good Manufacturing Practices (GMP); ISO 9001: 2008 and ISO 13485: 2012 Medical devices – Quality management systems – Requirements for regulatory purposes
“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
Vice President at Emcyte Pty Ltd
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.