IVDIAS Accelerates your IVDD-to-IVDR
Transition in the EU

IVDIAS offers fully integrated and modular services for biological products and
IVD kits, supporting every stage from concept to post-marketing surveillance.

Our flexible approach ensures tailored solutions to meet your specific needs.

Driven by innovation, we develop advanced products that enhance the
sensitivity of immunoassays and molecular biology techniques, including
rapid assays.

 images images images img images images images img images images images images
About Us

fully Integrated Services for Biological Products & IVD Kits

from idea to post-marketing surveillance.

What IVDIAS offers

  • Expert teams
  • Built-in quality systems
  • Clinical biobank access
  • Prospective Clinical sample collection
  • Fast-track technology transfer
  • Regulatory market support
  • Secure storage of kits and bioproducts
  • Distribution services
  • Post-marketing surveillance
Our Capabilities

IVDIAS's skills

  • Custom biomolecule engineering.
  • Adaptation to novel technologies.
  • Advanced analytics platforms: bioinformatics, metabolomics, genomics, proteomics, and more.

Why IVDIAS

Confidentiality

A non-negotiable.
Every project we take on is protected by a strict NDA.

Collaboration

We foster synergies across our start-up and biotech network to support your growth.

Credibility

We help you strengthen your credibility and reputation in the market.

Acceleration

We help you save time, reduce risk, and accelerate your path to market.

img
OUR SERVICES

Explore IVDIAS' Services

Cutting Through IVDR Complexity with the Right Partner

 

The IVDR has reshaped diagnostic product regulation, significantly affecting lateral flow tests. Outsourcing legal manufacturing to IVDR-compliant partners with robust QMS is now a strategic way to reduce complexity and ensure compliance.

Bringing Ideas to Life

 

We provide end-to-end support for diagnostic product development—from the initial concept through to market launch. Whether you’re starting with an idea or refining a near-final product, our team guides you through each critical stage, including design, validation, regulatory strategy, and manufacturing.
With deep expertise in both scientific and regulatory requirements, we help streamline your path to market while ensuring compliance, quality, and speed at every step.

Custom Bioproduction Backed by ISO 13485 Quality

 

In early IVD product development, many overlook the importance of controlling their supply chain. From our experience, bringing production of key materials, such as standards, antibodies, enzymes, plasmids, nanoparticles, and specialized beads, in-house is the best way to reduce risks, cut delays, and save costs down the line.

Your R&D Partner for Scalable Success

 

At IVDIAS, we act as your strategic R&D partner, not just a service provider. Our expert team co-invests with you in the development phase, ensuring faster progress, stronger foundations, and a clear path to industrialization.

img
Newsletter

Subscribe for Newsletter