Digital Health & SaMD Regulatory Enablement
The Growing Importance of Digital Health & SaMD
Digital health technologies are transforming patient care, diagnostics, and disease management. From mobile medical applications and digital therapeutics to AI-driven clinical decision support tools, Software as a Medical Device (SaMD) is reshaping how healthcare is delivered. However, innovation in digital health must be matched with robust regulatory, quality, and validation strategies. Regulatory agencies now expect digital health companies to demonstrate the same rigor in safety, effectiveness, data integrity, and lifecycle management as traditional medical products.
Regulatory Landscape for Digital Health Technologies
Digital health and SaMD products must navigate a complex and evolving regulatory environment, including:
FDA SaMD and Digital Health guidance
EU MDR and IVDR requirements
IMDRF SaMD framework
21 CFR Part 11 and Annex 11 for electronic records
Cybersecurity and data privacy expectations
Misinterpreting regulatory pathways or delaying compliance planning can result in approval delays, rework, or enforcement actions. BioNetwork Consulting helps you navigate this complexity with clarity and confidence.
Our Approach to Digital Health & SaMD Enablement
BioNetwork Consulting provides end-to-end regulatory enablement for digital health and SaMD products across the full lifecycle. Our approach includes:
Regulatory Pathway Assessment: Determine classification, submission type, and global strategy
Quality & Compliance Frameworks: Establish scalable QMS aligned with digital product development
Software Validation & CSV: Ensure systems meet GxP and FDA expectations
Risk Management: Apply ISO 14971 and SaMD-specific risk methodologies
Lifecycle Governance: Manage updates, AI model changes, and post-market obligations
This integrated approach accelerates market entry while minimizing compliance risk.
Key Benefits of Partnering with BioNetwork Consulting
Faster Market Access: Clear regulatory pathways and reduced rework
Regulatory Confidence: Alignment with FDA, EMA, and global expectations
Audit Readiness: Inspection-ready documentation and validated systems
Scalable Compliance: Frameworks that grow with your digital product
Cross-Functional Expertise: Regulatory, quality, CSV, and clinical insight in one partner
We support startups, scale-ups, and global enterprises bringing digital health innovations to market.
Digital Health & SaMD Services We Offer
Our comprehensive services include:
SaMD regulatory strategy and classification
FDA pre-submission and submission support
EU MDR and global regulatory planning
Software development lifecycle (SDLC) compliance
Computer System Validation (CSV) for SaMD platforms
Cybersecurity and data integrity support
Clinical evaluation and real-world evidence strategy
Post-market surveillance and change management
Ensuring Compliance, Validation, and Audit Readiness
Digital health products face intense regulatory scrutiny due to rapid software changes and evolving AI capabilities. BioNetwork Consulting ensures:
Validation strategies aligned with agile development
Traceability between requirements, risks, and testing
Audit-ready documentation for inspections
Change control processes for software updates and AI models
Alignment with 21 CFR Part 11, GxP, and global standards
Our proactive approach reduces compliance risk throughout the product lifecycle.