Performance Evaluation Report for a new diagnostic assay
An IVD manufacturer introducing a new diagnostic assay needed performance validation and a defensible Performance Evaluation Report.
Industry
Medical devices / IVD
Location
India
Services
Clinical Studies & PER
Category
Clinical Studies & PER
Clinical Studies & PERAn IVD manufacturer was introducing a new diagnostic assay that required performance validation. The team had a limited understanding of CDSCO performance-evaluation requirements, faced clinical performance data gaps, and had incomplete evaluation protocols and reports.
IVD Manufacturer
Client Type
Medical devices / IVD
Product Category
India
Target Market
Challenges Faced
- Limited understanding of CDSCO performance-evaluation requirements.
- Clinical performance data gaps.
- Incomplete evaluation protocols and reports.
Our Approach
- Developed a Performance Evaluation Plan (PEP) aligned to CDSCO expectations.
- Prepared the Performance Evaluation Report (PER) with full traceability.
- Coordinated clinical study documentation across the evaluation.
- Reviewed analytical and clinical performance data and supported regulatory submission requirements.
A clear path, milestone by milestone
Performance Evaluation Plan
Performance Evaluation Report
Clinical study documentation
Data review & submission
What it meant for the client
Successful acceptance of performance-evaluation data.
Smooth regulatory review process.
Faster product registration approval.
Key Results
Defined
Evaluation plan
Prepared
PER dossier
Accepted
Performance data
Smooth
Regulatory review
Every engagement is led by senior regulatory experts — with transparent milestones, complete documentation, and fixed-scope clarity from day one.
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