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.

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NEW SERVICES IN 2024!

• 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)