Medical device manufacturers

Medical Device Consultants

Our medical device consultants help manufacturers, sponsors and distributors in the Asia Pacific comply with requirements and standards, issued by organisations such as the US FDA CRF 820, and the ISO 13485:2016 Quality Management System for Medical Devices and ISO 14971 Risk management for medical devices. 

Our ISO 13485 consultants are experienced at providing a wide range of services, from our architects designing a new facility, through to our QMS / ISO 13485 consultants writing a Quality Management System. We believe that our consultants will be faster as we have a huge library of past projects to draw upon.

Our services include:

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 ...

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 ...

Validation Services

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

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. ...

GMP Project Management

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

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 ...

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 ...

GMP training

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