Quality Management

We have extensive experience in the development and implementation of Quality Management Systems to meet the requirements of ISO 9001 and 13485. Whether you are a virtual medical device manufacturer based in Australia but outsourcing your manufacturing to a manufacturing partner, or an Australian hands-on medical device manufacturer, we can assist in developing your Quality Management System to meet ISO 9001 and/or 13485, plus the required local Australian and/or European Regulatory Requirements.

After implementation, ongoing auditing services can be provided according to your requirements. We can also provide additional auditing services such as gap-analysis audits, pre-certification audits, sub-contractor audits, other supplier audits and due diligence audits. We have certified lead auditors for ISO 13485 available to assist with your audit needs.

In addition to this we can assist in developing your risk management plan, facilitate risk management workshops, and prepare your risk management report with you according to the requirements of ISO 14971.