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.
Regulatory Compliance Consulting
We can help with determining which regulations you need to comply with and how to achieve compliance without sacrificing business success.
Medical Device Registration in Australia
PharmOut offers consulting services for companies wishing to register medical devices with the TGA for sale within Australia.
Facility Design Reviews
Getting an independent review of your facility design is a great insurance policy – before the concrete is poured or you’ve signed the property lease.
Medical Device Vendor Management
We can help you find and qualify overseas manufacturers and suppliers for medical devices.
The “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 5: Audits of Manufacturer Control of Suppliers”, originally released by the GHTF (now IMDRF) should be used to audit your suppliers.
Audit Findings and 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 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
Continuous Improvement Consulting Services
PharmOut can demonstrate how to apply processes such as Lean Manufacturing and Six Sigma within the regulatory constraints of the Medical Device industry.
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 offers medical device project management services to help you get production up and running as well as in compliance with the relevant industry regulations.
We offer a full range of validation services, from cleaning validation and process validation to computer systems validation.
Get help finding permanent or temporary staffas well as contractors with specific technical skills and experience.
PharmOut frequently implements ISO 13485 Quality Management Systems (QMS) in medical device & IVD companies,compliant with ISO 13485:2016 and / or FDA QSR 820.
Medical Device Training Courses
PharmOut offers many medical device-specific training courses (including ISO 13485 and ISO 14971) online, on-site as well as in a city near you.
If you have questions you would like to ask, please contact us contact us at one of our offices around the world.
If you want to read more about medical devices, why not check out our blogs?