Health Data Privacy and Security Assessment
In-depth analysis and comprehensive report of health data privacy and cybersecurity requirements applicable to battery-operated ECG wearable medical devices in key markets
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
Business Plan and Market Analysis
US and Canadian market analysis and business plan for innovative patient handling system in various use cases
Fractional Regulatory Support
Ongoing regulatory affairs support for molecular testing IVDD company in global market
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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