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.
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.
Services in Scope
Scientific Validity Report / SOTA documentation
Clinical Performance Report preparation
Analytical Performance Report preparation
Product-wise data mining and evidence review
ZOTERO-based reference management
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
High-volume IVDR documentation across multiple product groups
Limited internal regulatory capacity to absorb additional workload
Need to consolidate product evidence across listed products
Intermittent addition of new products to project scope
Coordination across geographies and time zones
Need to maintain quality while reducing delivery cost
Solution
Freyr built a scalable regulatory delivery model focused on speed, ownership, and documentation consistency.
1
Conducted preliminary due diligence to define product and documentation needs
2
Grouped products into work buckets for structured execution
3
Created eight dedicated sub-teams with four members each
4
Assigned product buckets to sub-teams for clear ownership
5
Executed the project through 20 controlled delivery waves
6
Used ZOTERO to support reference management and traceability
Impact
Freyr helped the client move IVDR documentation readiness forward ahead of planned timelines while improving delivery predictability, cost efficiency, and documentation control.
Delivered 215 Clinical Performance Reports
Completed 159 SVR/SOTA documents
Delivered 44 Analytical Performance Reports
Achieved 100% on-time delivery across committed outputs
Reduced project cost by approximately 30%
Supported IVDR documentation readiness ahead of planned timelines
Strengthened data control, reference traceability, and stakeholder communication across delivery waves
