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Daniella Marx

Consultant - Toronto ON

Daniella is a Project Manager/Consultant based in Toronto who joined the Docusys team in May of 2022. Daniella is passionate about helping medical device manufacturers bring their medical technology to market and meet regulatory compliance. Her main areas of expertise are Quality Management and Risk Management. Daniella received a BSc in Biology from McGill University and a PhD in Biomedical Engineering from Toronto Metropolitan University. Her research in the field of implantable bone adhesives has been highly impactful in the field, and is published in several international Journals. 


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Daniella's Services

  • Represents clients as an outsourced Quality Manager for external ISO 13485:MDSAP audits.

  • Creates Quality Management documentation and tailors it to the manufacturers needs.

  • Provides training on documentation and ISO13485 /21CFR820 Requirements.

  • Liaises with external labs for electrical safety testing (IEC 60601), EMC and Biocompatibility testing (ISO 10993).

  • Create technical file documentation for Design and Development (ISO13485), Software Development (IEC62304), Risk Management (ISO14971) and Usability (IEC62366).

Questions?

To discuss your requirements, please do not hesitate to contact us.

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