Spectre Technology d.o.o.

https://www.startus.cc/company/spectre-technology

Savska cesta 32

10000 Zagreb

Croatia

Website

http://x.com/spectretechcom

General information:

Spectre Technology is a digital health company that improves the quality of life for patients with chronic diseases by delivering high-quality software and medical technology solutions. We act as a Critical Supplier/Subcontractor on projects developing software as a medical device (SaMD) and digital therapeutics (DTx) products under an ISO 13485-certified QMS. As a manufacturer of medical devices and IVDs, our company is registered in the Eudamed database under Actor ID/SRN HR-MF-000044251. We have an in-house process, and our expert teams handle every aspect of medical device strategy, product development, quality assurance, medical affairs, and regulatory compliance.

Company information:

Company type:

Company

Industry:

Healthcare / Medical Services

Founded when:

Thursday, 6 October, 2022

Startup stage:

Shipping stage (actively selling)

Types of jobs in the company:

Design / UX, IT - Backend, IT - Data, IT - Frontend, IT - Infrastructure, IT - Mobile, IT - Software Dev, IT - Web, Legal, Research & Development

Total numbers of employees:

Products and Services:

Software as Medical Device Development (SaMD)

Product category:

# Business services

We specialize in creating software solutions that are compliant with the highest medical standards and focused on SaMD. Our approach integrates cutting-edge technology with deep clinical insights to ensure that each SaMD product we develop is not only regulatory compliant but also delivers impactful health outcomes.

Digital Therapeutics Development (DTx)

Product category:

# Business services

Our treatment modalities are tailored to treat, manage, and prevent a wide range of medical conditions. Each DTx product is carefully crafted by blending medical expertise with digital innovation to provide evidence-based therapeutic interventions.

Quality Assurance, Regulatory Affairs

Product category:

# Business services

An accredited RA/QA partner providing consulting services for the complete lifecycle of medical devices and in vitro diagnostics (IVDs). Our team delivers expert guidance from the initial design phase through to the final stages of commercialization, ensuring compliance with all relevant regulations and quality standards.