Consulting Services

• Regulatory

  • Market Authorization in Australia, Europe, and the USA

  • Regulatory strategy development for global market entry

  • Preparation and submission of regulatory dossiers

  • TGA, FDA, and IVDR/MDR CE marking compliance

• Quality

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

  • ISO 17025 for Testing and calibration. ISO 15189 for Medical laboratories.

  • Risk management system (ISO 14971, ISO/TR 20416)

  • 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, ISO 9001, ISO 17025, ISO 15189)​

  • Support during your third party audits with you accredited body

• Product Design and Development

  • Feasibility studies​ / Proof of concepts

  • User needs / Design inputs / Design outputs

  • Verification / validation processes

  • Clinical Evaluation of MD & Performance Evaluation for IVDs

  • 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.

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NEW CONSULTING SERVICES IN 2025!

• Cybersecurity for Medical Devices

• AI for Medical devices

• Due Diligence services for acquisition of medical device and IVD companies (Technical, Quality and Regulatory) 

• ISO 17025 for calibration and testing

• ISO 15189 for medical laboratories and POC