Documedex

Exhibitor

At Documedex, we are dedicated to guiding medical device manufacturers, SaMD developers and Start-up companies through the complex world of regulatory and quality compliance. With a deep understanding of the global medical device regulatory landscape (Such as EU MDR, US FDA, Australia-TGA, UKCA, etc.), we help you navigate the stringent requirements to bring your products to market efficiently and safely.
We are committed to empowering companies by offering tailored, expert-driven solutions that not only ensure compliance but also foster innovation and growth in the medical device industry. Our services include:

• Regulatory strategy & Global market access across Australia (TGA), US (FDA), EU (MDR/CE), UK (UKCA) and more.
• Technical & Clinical documentation for global submissions, including preclinical studies, biological evaluation, software validation, usability study, risk management, Clinical Evaluation and clinical trial planning & reporting.
• Quality Management Systems implementation (ISO 13485, EU MDR, MDSAP).
• “QA/RA as a Service”: ongoing management of regulatory and quality functions.
• Grant applications, commercialisation planning, and market readiness. 
• Consulting for CE Certification (EU MDR 2017/745), US FDA (510K / DeNovo) and TGA (Conformity Assessment Certificate)
• Clinical Evaluation and Clinical Trial
• Usability Study (IEC 62366-1 / EN 62366-1)
• Software Validation (IEC 62304 - SaMD)
• Registration of medical device globally in over 110 countries.

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