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ABN: 34 718 284 574
 Regulatory Compliance Advice | |
| Assistance with determinations of the status and classification of your products in different world jurisdictions. | |
| Assessments of the regulatory obligations for your medical devices in your target markets. | |
| Recommendations for the most effective regulatory compliance paths for your medical devices. | |
| Business plans to achieve regulatory compliance for your medical devices in your markets. | |
| Existing Quality Management Systems Advice | |
| Analysis and recommendations for improvement to, or expansion of, existing Quality Management Systems. | |
| Assessments of existing processes and recommendations for improvements and additions if required. | |
| Assessments for conversion of ISO 9001 Quality Management Systems to certified ISO 13485 Systems. | |
| New ISO 13485 Quality Management Systems Building and Implementation | |
| Analysis of your existing processes and working patterns to form the basis of a custom made Quality Management System. | |
| Implementation of a new Quality Management System appropriate for your business. | |
| Management of the Certification process to ensure that your Quality Management System is implemented and appropriately certified. | |
| Technical Advice | |
| Advice to determine the best strategic approach to regulatory issues for your planned product. | |
| Analysis of your existing engineering solutions against the required standards and the essential principals. | |
| Advice on the best practice technical solutions to ensure the compliance of your medical devices in your target markets. | |
| Standards Guidance | |
| Advice on the appropriate international and local Standards to apply to the development of your product. | |
| Standards interpretation and guidance on the National deviations applicable to international markets. | |
| Risk Assessments | |
| Advice and guidance on the application of risk assessment methodologies to your medical devices. | |
| Advice and guidance on the application of risk assessment methodologies to your technical and business risks. | |
| Assistance with the application of the ISO 14971 risk assessment standard. | |
| Product Certifications | |
| Advice on the appropriate certifications for your local and international markets. | |
| Advice and guidance on the selection of a Certification Authority for international markets. | |
| Assistance with applications for, and the conduct of, product conformity assessments. | |
| Act as an agent for Australian TGA registrations and ARTG inclusion activities using DEAL. | |
For more information email info@medevice.com.au