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Digital Product Information as a Competitive Advantage in the World of Labs

 

 

What this webinar is about

Across Europe, clinical laboratories are increasingly building their own in-house IVDs—lawfully taking on responsibility themselves while using both RUO and CE-marked components. This shift is changing what labs expect from their suppliers.

More and more, they prefer manufacturers whose product information is easy to find, accurate, and readily available for compliance documentation. That preference is increasingly influencing purchasing decisions and tender outcomes.

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Why you should watch this webinar

The regulatory reality

Understand how in-house IVDs work, why they are legal and increasingly common, and where manufacturers fit within this framework while remaining fully aligned with their intended purpose.

What labs actually struggle with
See a live demonstration of how laboratories document in-house IVDs and manage manufacturer information, including IFUs, safety data sheets, and version-controlled documentation.

Why being on the platform pays off
Discover how seamless access to product information helps manufacturers become the preferred partner for laboratories, strengthens tender competitiveness, and reduces friction for customers.

Key topics covered

Market Shift & Opportunity
Growing adoption of in-house IVDs by laboratories.
Why this trend creates opportunities rather than threats for manufacturers.

Regulatory Reality

How in-house IVDs and RUO components are used legally.
Intended-purpose considerations and manufacturer protection.
Clear separation of responsibilities: laboratories remain responsible for the in-house IVD.

Live Product Demonstration

How labs document in-house IVDs using PlatoX.
Retrieval of correct manufacturer documentation (e.g., IFUs, SDSs, version-controlled information).
Reduction of manual documentation efforts.

Manufacturer Benefits

Becoming the preferred supplier when labs choose between comparable products.
Stronger positioning in large tenders and procurement projects.
Reduced friction for customers through seamless access to product information.

Future Outlook

Preview of manufacturer-focused compliance automation capabilities.
Risk Management (RM) and Performance Evaluation (PE) integration with existing eQMS systems.
Development roadmap overview (without commitments or timelines).

Q&A Session

Open discussion with regulatory and product teams.

Your Hosts of the Webinar

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bjorn_
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Andreas Oberleitner
Chief Regulatory Officer
Platomics
 
Björn Hansson
Product Development
Platomics
 
Elena Gromberg
Business Development
Platomics