Our Work

A selection of our past projects to see the practical outcomes of our specialized support across various challenges and industries.

Cybersecurity Training & Templates

Deliver training and develop SOPs and templates for new FDA premarket cybersecurity requirements

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Business Plan and Market Analysis

US and Canadian market analysis and business plan for innovative patient handling system in various use cases

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Fractional Regulatory Affairs Support

Ongoing regulatory affairs support for molecular testing IVDD company in global market

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MDSAP Gap Analysis & QMS Remediation for Tissue Regeneration Device Manufacturer

Comprehensive Canadian market entry support for novel wound management device, including regulatory strategy, QMS remediation, Canadian market analysis, procurement support.

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