Sina Strategy

Closing the gap between product development and regulatory readiness.

Fractional quality leadership for MedTech teams scaling products, strengthening systems, and preparing for audits or regulatory milestones.

Designed for MedTech teams that need senior quality leadership, but not a full-time headcount.

Talk Through Your Situation

Where MedTech Teams Break Down

Modern medical device teams, especially those scaling products and quality systems, often face a growing gap between how development actually happens and how it is expected to be documented.

  • Quality systems that don’t reflect how development actually happens
  • Product teams moving faster than quality and compliance systems can support
  • Traceability slowing development instead of enabling it
  • Misalignment between product, regulatory, and quality teams
  • Processes that break down as teams and products scale
  • Audit readiness requiring reactive, last-minute effort

The Impact

Left unaddressed, these issues compound into delays, audit findings, and expensive rework.

  • Slower development cycles and delayed releases
  • Increased audit risk and potential findings
  • Rework across teams and duplicated effort
  • Difficulty scaling systems across products and regions
  • Unclear ownership and decision-making
  • Growing friction between teams responsible for delivery and compliance

These issues rarely appear all at once, but they compound into audit findings, delayed releases, and costly rework.

Talk Through Your Situation

Experience Delivering in High-Stakes MedTech Environments

Quality and product leadership shaped by real-world regulatory, product, and commercialization complexity.

10+ Years Experience
Lead Auditor ISO 13485:2016
SaMD Expert IEC 62304 / TIR45
Global Compliance FDA & EU MDR
Experience supporting teams within leading MedTech organizations, including:
Abbott Johnson & Johnson Pfizer Philips Baxter

Where We Add Value

Focused support across quality leadership, product development, and compliance systems.

For teams that need senior quality leadership without adding full-time headcount

Fractional Quality Leadership

Senior quality leadership embedded within your organization, without the full-time overhead.

Embedded leadership to guide quality strategy, execution, and scale.

Outcome: Clear ownership, scalable systems, and reduced audit risk.

  • Acting Head of Quality / QA Lead
  • Quality strategy and roadmap development
  • Cross-functional leadership across R&D, regulatory, and product teams
  • Audit preparation and representation (FDA, Notified Bodies)
  • Ongoing QMS governance and performance monitoring
  • Mentorship and development of internal quality teams
Core focus area for software-driven & digital health

Product Development & System Strategy

Development systems that balance speed, compliance, and scalability across MedTech products.

  • SaMD development lifecycle design (IEC 62304, AAMI TIR45)
  • Agile implementation in regulated environments
  • Design controls modernization and simplification
  • End-to-end traceability architecture (requirements → testing → risk)
  • Modularization of software and system components
  • Product Development Process (PDP) redesign and governance

Quality Systems & Compliance

Build and scale quality systems that stand up to regulatory scrutiny, without slowing development.

Practical, scalable quality systems aligned to how teams actually work.

  • QMS design, build, and remediation (ISO 13485, 21 CFR 820)
  • SOP development, refinement, and harmonization
  • Internal audit readiness and execution
  • CAPA, complaint handling, and post-market surveillance processes
  • Design controls implementation (DHF, traceability, risk management)
  • Supplier quality and qualification frameworks

Organizational Alignment & Process Strategy

Get teams aligned on how work actually gets done, not just how it’s documented.

Clear operating models that align teams and reduce execution friction.

  • Cross-functional operating model design
  • PDP and SDLC alignment across teams and regions
  • Governance frameworks (decision-making, ownership, escalation)
  • Process simplification and standardization
  • Workshop facilitation for alignment, planning, and strategy
  • Change management support for new processes

Innovation & Emerging Regulatory Strategy

Where new technologies meet regulatory clarity.

Clear, defensible strategies for novel digital and software-enabled products.

Supporting organizations navigating AI, software-enabled products, and evolving regulatory expectations.

  • PDURS (Prescription Drug Use-Related Software) strategy and classification
  • AI/ML lifecycle considerations for medical devices
  • Label-integrated and digital companion product strategy
  • Evidence strategy for novel software and digital solutions
  • Regulatory pathway shaping (US and EU considerations)
  • Early-stage advisory for new product concepts
Talk Through Your Situation

Typical Engagements

Engagements are structured to address specific gaps—whether embedded leadership, focused sprints, or targeted advisory.

Selected Experience Highlights

  • Aligned cross-functional teams under a unified product development model
  • Defined a structured PDP framework across multiple teams
  • Clarified ownership, governance, and decision-making
  • Reduced ambiguity across product, regulatory, and quality
Result: Improved cross-functional alignment and reduced ambiguity across product development programs.
  • Enabled scalable development systems across software and hardware-integrated products
  • Designed development lifecycle aligned with IEC 62304 and agile practices
  • Implemented end-to-end traceability across requirements, testing, and risk
  • Supported modularization of system components
Result: Enabled faster development cycles while maintaining compliance expectations.
  • Improved audit readiness and reduced quality system friction
  • Refined SOPs and aligned processes to actual workflows
  • Strengthened CAPA and post-market processes
  • Supported audit preparation and execution
Result: Reduced audit risk and eliminated last-minute remediation effort.

Fix the Gaps Before They Show Up in Audits

If your team is facing quality, product development, or audit readiness challenges, it’s worth addressing them early.

A short conversation is often enough to identify the gaps and next steps.

Talk Through Your Situation