##  [Transforming IVDR Evidence Documentation into a Scalable Delivery Framework](/index%2ephp/success-stories/transforming-ivdr-evidence-documentation-into-a-scalable-delivery-framework) 

# Transforming IVDR Evidence Documentation into a Scalable Delivery Framework

Enabling high-volume CPR, SVR/SOTA, and APR delivery through 20-wave execution, on-time completion and cost-efficient regulatory support





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### 215



Clinical Performance Reports delivered







### 159



SVR/SOTA documents and 44 APRs completed







### 100%



on-time delivery with ~30% project cost reduction













![Client Overview]()



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## Client Overview



The client is a leading manufacturer of diagnostics and biomedical testing solutions, offering a wide range of products and services that support research and development across life sciences and related fields.











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## Background



The client was transitioning its IVD product portfolio from IVDD 98/79/EC to IVDR 2017/746. To keep the transition on track, the client needed specialized regulatory documentation support across scientific validity, clinical performance, and analytical performance requirements.





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## Services in Scope



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Scientific Validity Report / SOTA documentation



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Clinical Performance Report preparation



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Analytical Performance Report preparation



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Product-wise data mining and evidence review



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ZOTERO-based reference management















![Challenge]()



![Challenge]()

## Challenge



The client had to complete IVDR documentation for a large number of IVD products within defined timelines. With limited internal bandwidth, evolving scope, and stakeholders spread across regions, the project required strong delivery planning and close coordination.

#### Key Challenges

![Challenge]()

High-volume IVDR documentation across multiple product groups





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Limited internal regulatory capacity to absorb additional workload





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Need to consolidate product evidence across listed products





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Intermittent addition of new products to project scope





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Coordination across geographies and time zones





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Need to maintain quality while reducing delivery cost















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## Solution



Freyr built a scalable regulatory delivery model focused on speed, ownership, and documentation consistency.



1

![Challenge]()

Conducted preliminary due diligence to define product and documentation needs





2

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Grouped products into work buckets for structured execution





3

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Created eight dedicated sub-teams with four members each





4

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Assigned product buckets to sub-teams for clear ownership





5

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Executed the project through 20 controlled delivery waves





6

![Challenge]()

Used ZOTERO to support reference management and traceability











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## Impact



Freyr helped the client move IVDR documentation readiness forward ahead of planned timelines while improving delivery predictability, cost efficiency, and documentation control.



![Challenge]()

Delivered 215 Clinical Performance Reports





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Completed 159 SVR/SOTA documents





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Delivered 44 Analytical Performance Reports





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Achieved 100% on-time delivery across committed outputs





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Reduced project cost by approximately 30%





![Challenge]()

Supported IVDR documentation readiness ahead of planned timelines





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Strengthened data control, reference traceability, and stakeholder communication across delivery waves