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.

They are regulated within the Global Harmonisation Task Force (GHTF) guidance documents and, within some countries, 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

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

QMS development

If you need a new ISO:13485 Quality Management System (QMS) or updates to an existing one, PharmOut can provide the resouces and expertise. More