In Vitro Device manufacturers

In Vitro Devices (IVDs)

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 (old) Global Harmonisation Task Force (GHTF) guidance documents, i.e. the IMDRF. 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. ...

IVD registration

In Vitro Device (IVD) registration in Australia The Australian TGA regulates IVDs as a subset of medical devices, using a risk-based approach. Their regulatory framework aligns with the rec ...

GMP Contractors

If you are resource-poor and need experienced, professional GMP contractors to get a job done or a project completed, then we can supply contractors with a range of GMP skills and knowledge ...

Compliance Audits

PharmOut is privileged to have several consultants who have years of experience as TGA and PIC/S auditors. They know the relevant international regulatory codes for Medical Devices (with IVD ...

Audit findings responses

Receiving a notice of deficiencies after an audit by a regulator is never pleasant. For some companies it will mean major remediation efforts are required, for others it may mean having to a ...

Facility design reviews

Getting an independent GMP review of your facility design is a great insurance policy - before the concrete is poured or you've signed the property lease.We've known several companies wh ...

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. ...

QMS development

PharmOut frequently implements ISO 13485 Quality Management Systems (QMS) in medical device & IVD companies, compliant with ISO 13485:2016 and / or FDA QSR 820. ISO 13485 Quality Mana ...

Validation Services

We offer a full range of validation services, from cleaning validation and process validation to computer systems validation. ...

GMP training

PharmOut offers many Validation, GLP, GDP and GMP training courses. ...

GMP Project Management

PharmOut offers project management services to help you get production up and running and comply with the relevant regulations. ...