---
title: "上市后性能跟踪（PMPF） — Clinical Solutions | QbD Group"
description: "在 QbD IVD | Qarad，我们帮助您将 PMPF 转化为结构化、可落地的流程，保障合规与患者安全。"
url: https://qbdgroup.com/zh-cn/services/clinical-solutions/pmpf
type: "Page"
language: zh-cn
publisher: "QbD Group"
citation: "QbD Group, \"上市后性能跟踪（PMPF） — Clinical Solutions | QbD Group\", https://qbdgroup.com/zh-cn/services/clinical-solutions/pmpf"
---

# Post-Market Performance Follow-up (PMPF)

Proactive collection and evaluation of IVD data

At QbD IVD | Qarad, we help you turn PMPF into a practical, structured process—supporting your regulatory compliance and safeguarding patient outcomes.

## What is Post-Market Performance Follow-up (PMPF)?

PMPF, part of the broader PMS process, is the ongoing **proactive collection and evaluation of data** from real-world use of your IVD device.

Under IVDR, responsibilities don't end after CE marking. PMPF confirms performance and the risk-benefit ratio under routine conditions. It is an iterative process detecting emerging risks and ensuring continued acceptability.

## Pre-market vs post-market

Understanding the lifecycle obligations is key to compliance.

### Pre-market

Establish scientific validity, analytical performance, and clinical performance for the Performance Evaluation Report (PER).

### Post-market

Confirm continued validity of performance and benefit-risk ratio. Detect emerging risks and update state of the art.

## Common PMPF challenges we help you overcome

We provide tailored solutions to help you stay ahead without draining resources. IVD manufacturers often struggle with:

### Strategy

Defining a clear PMPF strategy and plan.

### Screening

Systematic and objective literature screening.

### Validation

Confirming clinical performance and scientific validity.

### Updates

Keeping up with state of the art and regulatory changes.

### Vigilance analysis

Analyzing vigilance databases and manufacturer's internal data.

### Resource management

Managing resource peaks for recurring PMS activities.

### Documentation

Ensuring timely and audit-ready documentation.

## Common PMPF activities

| Type of method | Examples

| Scientific validity | Literature search (protocol & report)

| Clinical performance | Literature search, evaluation of registries

| Vigilance data analysis | Database screening

| State of the Art review | Monitoring guidelines, scientific literature

| Optional methods | EQA schemes, registries, PMPF studies

为什么选择QbD Group

## 您值得信赖的合作伙伴

We support IVD manufacturers with hands-on PMPF expertise, offering a full-service solution tailored to your needs. Thanks to our medical writing expertise, regulatory know-how, and deep understanding of IVDs, we offer a time- and cost-effective solution to meet IVDR requirements with confidence.

Developing your PMPF strategy and plan.

Executing literature and database searches.

Analyzing internal and external data sources.

Preparing compliant PMPF documentation.

Updating your PER and Risk Management File.

✔️ IVDR-compliant | ✔️ Customized approach | ✔️ Proven track record with global IVD leaders

## 规划您的临床路径

从差距评估到完整 CRO 交付,我们的临床专家随时为您的 MedTech 旅程提供支持。

联系我们

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Source: https://qbdgroup.com/zh-cn/services/clinical-solutions/pmpf — © QbD Group. Quote freely with attribution and a link back.