AI-powered · Expert-verified · IVD medical devices
Medical device dossier support for IVD and diagnostic products
Medical device dossier preparation for IVD, diagnostic, and point-of-care products targeting Singapore and Malaysia.
Singapore and Malaysia professional fees from SGD 1,149.
Designed for
Medical device dossier support for IVDs and diagnostics
For IVD manufacturers, diagnostic distributors, point-of-care product companies, and regional commercial teams. Everest Nova prepares documentation for client submission; regulator approval remains independent.
Where projects stall
The market-access problem is usually a documentation problem first.
Performance evidence, IFUs, labeling, intended use, and manufacturing documents must tell one consistent story.
Diagnostics often need fast launch timelines but careful evidence organization.
Regional distributors need a dossier workflow that works with overseas manufacturers.
What Everest Nova prepares
- Diagnostic product evidence checklist
- Performance and labeling document map
- Country-specific gap questions
- Expert-reviewed package for client submission
Scope and market
The Everest Links history includes rapid antigen tests, ultra-rapid PCR, dengue testing, allergy testing, and point-of-care diagnostics from Singapore.
A coordinated Singapore + Malaysia bundle and both eligible local-support options are available.
Next step
Start with a structured intake, not a messy email thread.
AI-assisted screening helps focus the first document requests; medtech experts verify the context, prepare the work, and control final delivery through the Everest Nova portal.
Everest Nova professional service fees are separate from government, regulatory authority, CAB, conformity-assessment, licensing, registration, and other third-party fees. Customers are responsible for paying those fees directly where applicable. Everest Nova prepares submission-ready regulatory dossiers. Direct submission to regulatory authorities is not included.
Everest Nova prepares documentation packages for client submission and does not guarantee regulatory approval. Approval outcomes depend on the product, evidence quality, data completeness, manufacturing controls, and the independent assessment of the relevant authority.
Also see Singapore regulator guide and Malaysia regulator guide.