In Vitro Devices (IVDs) are typically treated as a subset of medical devices. They provide information for diagnostic, monitoring or compatibility purposes by means of in vitro examination of specimens derived from the human body e.g. blood, tissue, urine and hair.

In most cases IVDs are regulated within the Global Harmonisation Task Force (GHTF) guidance documents. This is not the case for all as some countries govern IVDs by separate regulations.

Our services include:

Regulatory compliance consulting

We can help with determining which regulations you need to comply with and how to achieve compliance without sacrificing business success.More

IVD registration

Registration strategies and submissions for companies wishing to supply in vitro devices into the Australian market. More

Compliance contracting

We can supply experienced industry professionals to help complete a project or support remediation activities. More

Compliance audits

Our auditors can perform a mock audit to determine if you are ready for a GMP audit by a regulator, or need to make improvements. More

Audit findings responses

If you've just been audited by a regulator, we can help you with your response to the audit compliance report. More

Facility design reviews

Before you spend money on new or updated facilities ensure the design will make both compliance and manufacturing easy. More

Supplier audits

PharmOut offers a third party audit service that allows several customers of a specific supplier to share the costs of an audit. We can also perform on-demand audits of your suppliers. More