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Acrapack Regulatory Consultants

Acrapack regulatory consultants what we do

Dedicated regulatory professionals offering a high quality consulting service that supports and provides the objectivity to get the work done.

  • Prepare and review of Medical Device and Invitro Diagnostics (IVDs) regulatory submissions
  • Submit Medical Device and Invitro Diagnostics (IVDs) regulatory submissions (510(k) notifications, European CE Mark, Canadian CMDR, Australian TGA Class III and Conformity Assessment
  • Complete US FDA Medical device and Invitro Diagnostics (IVDs) registrations and listings
  • European CE marking Medical Device and Invitro Diagnostics (IVDs) dossier preparation and review
  • Prepare new product regulatory and quality system documentation to support Australian and international assigned Medical Device and Invitro Diagnostics (IVDs) projects
  • Medical device and Invitro Diagnostics (IVDs) Technical dossier reviews
  • Implement integrated ISO 13485 and FDA quality system requirements (QSR)
  • Regulatory advice and consulting support for post market requirements
  • Prepare Medical Devices and Invitro Diagnostics (IVDs) Technical Files
  • Process and Systems reviews
  • Strategic Planning for Australian and international Medical Device and Invitro Diagnostics (IVDs) regulatory and quality system requirements
  • Internal quality system audits
  • Gap analysis for ISO 13485 Quality Management System and Medicine GMP
  • Medical Device and Invitro Diagnostics (IVDs) Supplier due diligence and assessment audits
  • Medical Device and Invitro Diagnostics (IVDs) Product labelling reviews
  • Training in Australian Medical Device and Invitro Diagnostics (IVDs) regulations, FDA QSR, ISO 13485, internal auditors

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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.”

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ACRA regulatory services as your Medical Device sponsor in Australia or New Zealand or in both countries

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

Find out more about how we can assist as your Australian or New Zealand sponsor or as your sponsor for both countries

Acrapack is proud to be a member of the following associations

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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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