Bioexcel
Post-Market Evidence

PMS / PSUR

Transform post-market data into structured safety, performance and benefit-risk evidence for lifecycle reporting.

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HomeServicesPMS / PSUR
When This Service Is Needed

Needed on an ongoing basis once a device or product is on the market, and specifically ahead of each scheduled PSUR/PMS reporting cycle.

How Bioexcel Approaches the Requirement

Bioexcel reviews complaint trends, exposure data and safety signals, integrates them with PMCF and Risk Management, and writes the PSUR with an updated benefit-risk conclusion.

Scope of Support

What Bioexcel Provides

PMS planningComplaint trend analysisExposure contextSafety signal reviewPSUR writingBenefit-risk updatesCER linkage
Key Deliverables
  • PMS Plan / Report
  • Complaint trend analysis
  • PSUR
  • Updated benefit-risk conclusion
Data / Regulatory Interfaces

Feeds directly into CER updates, Risk Management and Notified Body reporting.

Typical Engagement Model

Full-Service PartnershipFunctional Service ProviderProject-Based SupportConsulting & Advisory
Related Services
Clinical Evaluation / CERSafety Management & VigilancePMCF
HIPAA Compliant
ICH-GCP Compliant
FDA 21 CFR Part 11
ISO 9001
ISO 14155
ISO 27001 Certified
EU MDR 2017/745
EU IVDR 2017/746
US FDA Requirements
ISO 20916

Discuss Your PMS / PSUR Requirement

Share your program details and Bioexcel can help scope the right level of support.

Discuss Your RequirementRequest a Proposal