AI readiness screen
Surfaces likely gaps from product context and the file inventory.
AI-powered · Expert-verified
AI-powered medical device dossiers. Expert-verified.
Everest Nova combines regulatory AI with experienced medtech review to surface likely documentation gaps sooner and prepare submission-ready dossiers for Singapore and Malaysia.
Singapore dossiers from SGD 799
AI-assisted readiness and gap screening
Human medtech judgment before delivery
Everest Nova AI
Regulatory intelligence first. Human accountability throughout.
AI screens structured project context and the uploaded file inventory to flag likely missing or unclear document categories and prepare focused follow-up requests. A medtech expert verifies the findings and controls the dossier work that follows.
See how Everest Nova AI worksFocused requests
Turns gap signals into prioritized, client-facing next actions.
Expert verification
Medtech specialists review context and retain final judgment.
AI supports document-readiness screening. It does not predict approval, replace regulatory judgment, or make authority decisions.
The problem
Distribution rights are not enough.
Singapore and Malaysia submissions are complex. We add the local structure and market knowledge needed to turn scattered files into a clear dossier package.
Company, product, and manufacturer files in different places
Different HSA and MDA expectations
Local market knowledge missing from the team
Portal
A simpler way to move the dossier forward.
Your team gets one place to upload files, answer questions, track status, and download the final package.
Client portal
Dossier in progress
UploadSource files
AI screenGap signals
ExpertMedtech review
PrepareDossier package
DeliverClient download
Files
Messages
Deliverables
Intake and classification review
Tell us the intended use, proposed class, target market, and existing approvals. Everest Nova confirms the classification, scope, and exact price before payment.
Upload all source documents
Upload your company information, product details, manufacturer-provided documents, labels, IFUs, certificates, quality files, and evidence.
AI-assisted readiness review
Everest Nova AI screens project context and the uploaded file inventory to flag likely missing or unclear document categories and draft focused follow-up requests.
Medtech expert review
In-house medical technology specialists review the source material and project context before dossier preparation begins.
Why we built Everest Nova
Fifteen years of seeing the same regulatory bottleneck.
After working across hundreds of regulator-facing product registrations through Everest Links, we saw how often new market entrants were slowed by fragmented documentation and limited regulatory bandwidth. Everest Nova combines that experience with responsible AI to make the path clearer and more affordable.
Our current focus is medical-device dossier preparation for Singapore and Malaysia. The larger mission is to reduce avoidable friction so useful healthcare technologies can reach clinicians and patients sooner—always subject to independent authority review.
Read why we built Everest NovaWhere we help
Medical device dossiers.
We prepare regulatory dossiers for medical devices, including IVDs, diagnostic products, and point-of-care devices, for Singapore and Malaysia market access.
AI-powered dossier preparation workflow
AI-assisted readiness screening helps surface likely documentation gaps early; medtech experts verify the project context, prepare the dossier, and control final delivery.
Country and bundle packages
Choose Singapore, Malaysia, or one coordinated Singapore + Malaysia dossier workflow with country-specific adaptation.
Credibility
Built from Singapore medtech experience.
Everest Nova is rooted in Singapore and connected to Everest Links Pte Ltd, an ISO13485 and GDPMDS certified company with 15 years in medical devices and diagnostics.
Visit Everest Links parent websiteAI + expert
AI-assisted gap screening with human medtech verification
Singapore
home base for regional Singapore and Malaysia market access work
15 years
medical device and diagnostics experience through Everest Links
ISO13485
quality-management certification foundation
GDPMDS
Singapore good distribution practice medical device systems foundation
Expert review
medtech specialists review the material before dossier delivery
Pricing
Fixed pricing for each confirmed device class.
Choose Singapore, Malaysia, or a coordinated two-market bundle, then see the exact professional fee for Classes A–D. Optional support is clearly itemized before checkout.
Package highlights
Regulatory classification confirmation
Applicable registration pathway identification
Structured regulatory intake
Secure document-upload workspace
Review of customer-provided manufacturer documents
AI-assisted initial completeness and gap assessment
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.
Ready to turn your files into a dossier package?
Start with a secure account. Upload your files. We take it from there.