Regulatory Strategy & Registrations
End-to-end guidance on FDA 510(k), EU MDR/IVDR, Health Canada, tFDA; tailored pathways for IVDs and combination products.
- Deep-dive regulatory gap analyses & submission planning.
- Liaison with notified bodies and regulators.
FDA US Agent & Official Correspondent
For Foreign Establishments, assign us as your point of contact for US FDA Establishment Registration. Let us complete any ESG requests on your behalf.
- Official Correspondent &/or US Agent.
- eMDR Reporting (ESG).
Clinical Study Services
Assistance with Clinical Study Strategies and Efficient Data Collection for medical device trials.
- Clinical evaluation planning and protocol development.
- Data collection strategy and management.
Quality Systems & Auditing
Build, implement, and certify robust QMS to ISO 13485 and MDSAP standards, plus procedural support for FDA QSR (21 CFR 820) .
- QMS gap assessments & SOP development
- Internal audits, supplier audits & eMDR reporting
Software & Cybersecurity Services
From software V&V to IEC 62304 cybersecurity documentation, ensuring your device software meets global safety & security requirements
- Software requirement specs & hazard analyses
- Verification & validation protocols and test plans
MDVICEFUSION AI‑Driven Total Solution Platform
Leverage our in‑house AI platform to generate automated market research, competitive landscapes, and data‑driven regulatory pathway reports
- Customizable AI‑powered dashboards & ROI models
- Real‑time competitor intelligence & pricing benchmarks