About

Focused regulatory preparation for Singapore and Malaysia.

Everest Nova prepares medical device dossiers, including IVD and diagnostic device dossiers, with in-house medtech expert review.

Everest Nova is based in Singapore and built for companies seeking Singapore and Malaysia market access. Our typical client is a distributor or market-access team with rights to sell an imported medical device—including an IVD or diagnostic product—but without the internal bandwidth to turn company, product, and manufacturer-provided documents into a clean regulator-facing dossier package.

Everest Nova is connected to Everest Links Pte Ltd, our Singapore medtech foundation. Everest Links Pte Ltd is an ISO13485 and GDPMDS certified Singapore medtech company with 15 years of experience across medical devices, diagnostics, oncology, infectious disease, allergen diagnostics, point-of-care solutions, rapid antigen tests, pulse oximeters, ultra-rapid PCR, dengue testing, and allergy testing.

That history matters for dossier work. We are not approaching regulatory documentation as a generic paperwork service; we come from a business that has worked with real diagnostic products, medical equipment, clinical-use contexts, installation, servicing, decommissioning, and distribution realities in Singapore.

Visit Everest Links parent website

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

Singapore home base

We are positioned from Singapore, close to HSA expectations and regional ASEAN market-access realities.

Certified medtech foundation

Everest Links is ISO13485 and GDPMDS certified, giving Everest Nova a stronger healthcare-quality narrative.

Operating product history

The Everest Links history spans diagnostics, POC products, rapid tests, oximeters, PCR, dengue, and allergy testing.

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.