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 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. With a huge library of past projects to draw upon, our consultants are guaranteed to be faster and more effective.
We can help with determining which regulations you need to comply with and how to achieve compliance without sacrificing business success.
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 address a few small issues. PharmOut can help you prepare your audit response.
PharmOut is privileged to have several consultants who have had years of experience as TGA and PIC/S auditors. They know the relevant international regulatory codes for Medical Devices
If you are resource-poor and need experienced, professional contractors to help get a job done or a project completed, then we can supply contractors with a range of skills and medical device knowledge.
PharmOut frequently implements ISO 13485 Quality Management Systems (QMS) in medical device & IVD companies,compliant with ISO 13485:2016 and / or FDA QSR 820.