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Consulting Services

  • Regulatory

    • Person Responsible for Regulatory Compliance (MDR/IVDR)

    • Transition from IVDD/MDD to IVDR​/MDR

    • Post-Market surveillance 

    • Clinical Evidence 

    • Clinical performance studies

    • Products registration

    • State of the art

  • Quality

    • Implementation and maintenance of the QMS (ISO 13485 and ISO 9001)

    • Risk management system (ISO 14971)

    • Software as a Medical Device - SaMD (IEC 62304 and IEC 82304-1 standards)

  • Audit

    • Independent audits for compliance with QMS Internal Audit process (ISO 13485)​

    • Support during your third party audits with you accredited body

  • Product Design and Development

    • Feasibility studies​ / Proof of concepts

    • Verification / validation processes

    • Performance Evaluation process

    • Analytical and Clinical data analysis

  • Training

    • Training courses on Quality and Regulatory Affairs for Medical devices and IVDs.​

  • Scientific Marketing

    • Technical notes for manufactures of medical devices

    • Technical brochures for products

    • Scientific Webinars 

  • Australia/NZ Sponsorship for Medical Devices/IVDs

    • Sponsorship services

    • Regulatory support for product submission


For more information about these services please contact us in our chat box.


  • Australian and NZ Sponsorship for Medical Devices (overseas manufacturers)

  • eQMS implementation, from paper to electronic Quality Management System for Medical Device Manufacturers

  • Due Diligence services for Medical device companies and IVD companies (Technical, Quality and Regulatory) 

Let us know what you need

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