Medical Devices

PharmOut helps medical device manufacturers in the Asia Pacific comply with requirements and standards, issued by organisations such as ISO, GHTF, FDA, EMA etc.

Our services include:

Regulatory compliance consulting

We provide compliance advice that supports both your regulatory requirements and business demands. More

Device registration

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

Facility design reviews

Before you spend capital on new facilities make sure the design will make both compliance and manufacturing easy. More

Sourcing offshore manufacturers

We can help you find and qualify overseas manufacturers and suppliers. More

Compliance Audits

Our auditors can perform a mock audit to determine if you are ready for a regulatory conformity assessment, 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

 

Validation services

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

Project Management

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

Compliance Contracting

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

Recruitment

Get help finding permanent or temporary staff with specific technical skills and experience. More

QMS development

If you need a new ISO:13485 or QSR 820 compliance Quality Management System (QMS) or updates to an existing one, PharmOut can provide the resouces and expertise. More

Training

PharmOut's training courses range from an Intro to ISO 13485 to Validation and Auditing. Book classroom training or learn about our eLearning options. More