Provide regulatory compliance consulting medical devices to medical device manufacturers and sponsors across the Asia Pacific region, mainly to the Australian TGA requirements.
We can help with determining the classification of your medical device, and the applicable regulatory codes that govern the regions you plan to supply product to.
This can get tricky when a medical device incorporates a medicine or you are producing procedure packs that include multiple devices in one pack – should you register the pack as individual components or a whole pack?
More about our device registration services
Manufacturing Licenses / ISO 13485 Certification
PharmOut’s regulatory compliance consultants for medical devices can help you setup the systems and processes in order to get the appropriate licenses and certifications from the regulatory and or notified bodies. This includes determining the appropriate quality management system to use and then helping you build the QMS to the appropriate standards. If you have a QMS that isn’t working or has been cited in an audit report then we can help you remediate it.
If you’ve been audited by a regulator or are about to be, we can help you troubleshoot and solve specific GMP compliance issues. This may include conducting a mock audit or reviewing the findings from a regulatory audit to determine the best course of action.
Please contact us to discuss your needs or to obtain a quote.