NKB Regovanta - Global Regulatory, Quality & Market Access Consulting
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Harmonized Multi-Market Strategy

Planning for Global Market Access

We plan regulatory evidence across target markets so common testing and technical documentation can be leveraged where scientifically and regulatorily appropriate, while market-specific gaps are identified early.

Build Your Global Regulatory Strategy

Strategic Alignment

One Product. Multiple Markets. One Strategically Aligned Evidence Plan.

What This Service Is

A product intended for several markets should not automatically become several unrelated regulatory projects. A coordinated evidence strategy can reduce duplication and improve consistency while still respecting jurisdiction-specific requirements.

When It Is Needed

When the same Medical Device or IVD is planned for US, EU, India or other markets
Before major testing programs are initiated
When the manufacturer wants to avoid repeating equivalent studies for different jurisdictions
When existing technical documentation must be adapted for additional markets
When manufacturing and quality planning must support international expansion

Our Regulatory Planning Model

Target Markets → Regulatory Requirements → Common Evidence → Market-Specific Gaps → Submission Strategy

Evidence We Evaluate for Alignment

Biocompatibility (ISO 10993 global standards)
Sterilization validation (ISO 11135 / 11137)
Packaging and shelf life (ISO 11607 / ASTM)
Electrical safety and EMC (IEC 60601 family)
Software and cybersecurity (IEC 62304 / FDA guidance)
Risk management file (ISO 14971)
Human factors & usability engineering (IEC 62366)
Performance testing & bench studies
Clinical evidence & Clinical Evaluation Reports (CER / PER)
IVD analytical and clinical performance
Quality-system documentation (MDSAP / ISO 13485 / QMSR)
Technical documentation / STED dossiers
Our Difference

True Cross-Jurisdiction Evidence Leverage

We do not simply list countries where registration is possible. We identify which evidence can legitimately be leveraged across markets and which regulatory gaps remain market-specific.

Global Target Jurisdictions

  • United States (US FDA 510(k), De Novo, PMA)
  • European Union (EU MDR 2017/745, IVDR 2017/746)
  • India (CDSCO Medical Device Rules 2017)
  • UK, Australia, Canada, Brazil, Saudi Arabia & UAE

Multi-Country Launch?

Design your testing and technical documentation once to serve multiple global health authorities.

Build Global Strategy

Ready to Plan Your Multi-Market Regulatory Roadmap?

Our international regulatory consultants align your evidence strategy to accelerate worldwide approvals.

Book a Consultation