How can we help?
Empowering Digital Health Start-ups and MedTech companies with expert consulting and technology services to ensure regulatory compliance, optimize operations, and deliver transformative patient outcomes. We partner to streamline product development, enhance compliance, and harness real-world data for success in diagnostics, treatment, and care.
SaMD Development
Build innovative AI-driven medical and IVD devices to enhance diagnostics, treatment, and patient care.
Usability Engineering
Design intuitive interfaces to enhance medical device safety and effectiveness, complying with ISO 62366 standards.
Risk Management
Enable safety and security risk management for medical devices, ensuring compliance with ISO 14971 standards.
Clinical Evaluation
Generate pre-market and post-market clinical evidence to ensure medical device safety and effectiveness.
Quality Management
Implement and optimize robust QMS processes to comply with ISO 13485, FDA QMSR, and other regulations.
Regulatory Affairs
Navigate regulatory pathways and streamline submissions to ensure compliance and accelerate market access
Materiovigilance
Drive continuous safety and effectiveness of the medical device through post-market surveillance and vigilance.
Digital Modernization
Harness AI, Data Analytics, Cloud, and advanced technologies to transform business processes.
Our Expertise
Strategy Consulting
Helping digital health companies navigate industry complexities, optimize operations, and drive innovation through strategic insights.
IT Consulting
Providing technology solutions, AI/ML, data strategy, cybersecurity, cloud, and digital transformation to accelerate healthcare innovations and outcomes.
Digital Product Management
Managing and shaping the product vision, overseeing development, ensuring regulatory compliance, and driving user adoption.
Business Analysis
Engaging with customers and stakeholders to identify opportunities, define requirements, and align technology solutions with business goals.
Program Management
Driving program and project management activities across the entire medical device value chain to ensure successful delivery and regulatory compliance.
Regulatory Consulting
Delivering expert quality and regulatory consulting to ensure compliance, streamline processes, and support successful product approvals and market access.
Business Operations
Improving operational efficiency, compliance, and performance across clinical, quality, regulatory, vigilance, and medical affairs through global delivery models.
Staffing Services
Supplying highly skilled industry professionals and IT experts for projects, operations, and long-term success on a contractual basis, both onsite and remotely.