Consulting Services
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Regulatory
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Person Responsible for Regulatory Compliance (MDR/IVDR)
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Transition from IVDD/MDD to IVDR/MDR
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Post-Market surveillance
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Clinical Evidence
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Clinical performance studies
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Products registration
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State of the art
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Quality
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Implementation and maintenance of the QMS (ISO 13485 and ISO 9001)
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Risk management system (ISO 14971)
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Software as a Medical Device - SaMD (IEC 62304 and IEC 82304-1 standards)
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Audit
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Independent audits for compliance with QMS Internal Audit process (ISO 13485)
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Support during your third party audits with you accredited body
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Product Design and Development
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Feasibility studies / Proof of concepts
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Verification / validation processes
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Performance Evaluation process
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Analytical and Clinical data analysis
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Training
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Training courses on Quality and Regulatory Affairs for Medical devices and IVDs.
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Scientific Marketing
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Technical notes for manufactures of medical devices
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Technical brochures for products
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Scientific Webinars
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Australia/NZ Sponsorship for Medical Devices/IVDs
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Sponsorship services
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Regulatory support for product submission
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For more information about these services please contact us in our chat box.
NEW SERVICES IN 2024!
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Australian and NZ Sponsorship for Medical Devices (overseas manufacturers)
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eQMS implementation, from paper to electronic Quality Management System for Medical Device Manufacturers
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Due Diligence services for Medical device companies and IVD companies (Technical, Quality and Regulatory)