AI-powered · Expert-verified · Diagnostic medical devices
Medical device dossiers for diagnostic and IVD companies
Expert-reviewed medical device documentation support for diagnostic, IVD, rapid test, and point-of-care product companies.
Singapore and Malaysia professional fees from SGD 1,149.
Designed for
Diagnostic dossier preparation
For diagnostic companies, IVD manufacturers, distributors, and POC product 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, intended-use claims, labels, and IFUs must be aligned.
Commercial urgency is high, especially for infectious disease and point-of-care products.
Regulatory files need a careful human review before delivery.
What Everest Nova prepares
- Diagnostic evidence document map
- IFU and labeling organization
- Gap review for performance evidence
- Submission-ready package for client use
Scope and market
Everest Links' Singapore diagnostics history gives the service a practical understanding of IVD documentation.
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.