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:
We can help with determining which regulations you need to comply with and how to achieve compliance without sacrificing business success.More
Registration strategies and submissions for companies wishing to supply in vitro devices into the Australian market.
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.
If you've just been audited by a regulator, we can help you with your response to the audit compliance report.
Before you spend money on new or updated facilities ensure the design will make both compliance and manufacturing easy.
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
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
Learn how we apply the processes used in other industries, such as Lean Manufacturing and Six Sigma within the constraints of a regulated industry.
We offer a full range of validation services, from process validation to computer systems validation.
PharmOut's training courses range from an Intro to ISO 13485 to Validation and Auditing. Book classroom training or learn about our eLearning options.
PharmOut offers project management services to help you get production up and running and comply with the relevant regulations.
Get help finding permanent or temporary staff with specific technical skills and experience.