---
title: Clinical Investigations For Medical Devices | Safety and Performance | FTR Adviso
description: We provide full-service or tailored to your needs for clinical investigations or post-marketing surveillance
image: https://www.ftradvisor.com/hubfs/indagini-cliniche-ftr-advisor.webp
---

![bg-ftr-advisor (7)-2](https://www.ftradvisor.com/hubfs/bg-ftr-advisor%20(7)-2.jpg)

# CLINICAL INVESTIGATIONS FOR MEDICAL DEVICES (MDR)

## **Designing and conducting clinical studies to demonstrate safety, performance, and clinical benefit**

Certification of a medical device, according to Regulation (EU) 2017/745, is supported by appropriate clinical data that can confirm or demonstrate its safety, performance or efficacy. Each device has its own pathway: there is no "one-size-fits-all prescription." By designing a pre-market clinical investigation or by designing a proactive post-market surveillance plan, you can collect clinical data, actual use data, feedback, reports, and manage complaints/noncompliance in a structured way.

The study design must be methodologically sound, statistically justified, and consistent with:

- Annex XV MDR
- ISO 14155
- Clinical Evaluation Plan (CEP)
- Risk Management
- Claim and intended use of the device

FTR Advisor supports in **defining clinical strategy, methodological design, conducting and reporting** of pre-market and PMCF prospective clinical trials.

## **When is a clinical study required?**

A clinical investigation may be required in the following cases:

- Class III and implantable devices
- Inability to demonstrate clinical equivalence
- Innovative devices or devices with new technologies
- New indications for use
- Need to collect new or more data
- Confirm benefit/risk profile
- Verify real-world performance
- Collect data on specific subpopulations

# Our methodological approach

## *1. Defining the clinical strategy*

- Analysis of clinical rationale, intended use, and claims
- Check for consistency with defined endpoints with clinical benefits
- Rational justification of *sample size*

## *2. Documentary design*

Drafting and structuring of:

- Clinical Investigation Design Gantt.
- Synopsis
- Clinical Investigation Plan (CIP)
- Investigator's Brochure
- e-Case Report Form (e-CRF)
- Monitoring Plan
- Documentation for Ethics Committee
- Documentation for Competent Authority

Each document is developed consistent with CEP, GSPR and Risk Management.

## *3. Study initiation and conduct.*

- Coordination with clinical centers
- Monitoring and supervision
- Management of deviations and adverse events
- Quality control of collected data

The goal is to ensure data integrity and regulatory compliance.

## *4. Statistical analysis and reporting*

- Statistical analysis according to predefined plan
- Clinical Investigation Report (CIR)
- Integration of results into the ERC

Why **FTR ADVISOR?**

- Experience
- Integrated approach: regulatory, clinical, and quality across the lifecycle
- Constant alignment to regulation, guidelines, ISO standards, and practice
- Focus on regulatory risk reduction and *rework*

 Are you looking for an experienced and reliable CRO for medical device consulting?

 We design and manage all phases of the clinical investigation through our team of highly qualified professionals.

[Let's get in touch](https://www.ftradvisor.com/en/contacts)