Regulatory AI grounded in real medtech experience.

Our technology is designed to accelerate the disciplined early work: screening structured project context and the file inventory, surfacing likely documentation gaps, and preparing focused next actions. Human medtech specialists remain responsible for regulatory judgment and dossier delivery.

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 and work across hundreds of regulator-facing product registrations. Its operating history spans 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.

We built Everest Nova because we experienced the same problem our clients face: valuable products can be slowed by fragmented files, unclear requirements, and limited regulatory bandwidth. AI gives us a practical way to make the early work more focused and affordable; experienced people remain accountable for the result.

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.