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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

Preparing patient for transfer using lifting device

Business Plan and Market Analysis

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

Fractional Regulatory Affairs Support

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

MDSAP Gap Analysis/MDL 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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