Manufacturer's clinical evaluation report-bg

Manufacturer's clinical evaluation report

The manufacturer's clinical evaluation (report) is a key document in proving clinical effectiveness and safety in clinical trials in the form of the clinical evaluation. The report is generally based on the requirements of MEDDEV-2.07-1-rev 4 Clinical Evaluation: Guidance for Manufacturers and Notified Bodies.

Clinical evaluation is conducted by collecting and analyzing clinical literature regarding the intended use of the medical device and includes the following key points:

Identification of the intended use and planning of the clinical evaluation,

Identification of relevant data (standards and clinical data)

Evaluation of each individual data set for scientific validity, relevance and weighting, including:

Searching and analyzing literature publications supporting the safety and effectiveness of the medical device.

Providing data for the period of commercialisation of the medical device to confirm safety and effectiveness

Demonstrating equivalence between the intended use and claimed properties and performance and safety of the medical device and a device that has already been on the market.

Analyzing the data through which conclusions are drawn about the key claims related to clinical effectiveness and safety, including the total clinical risk/benefit, analyses of information in the user manual (instructions for use), residual risks and PMS (post-market surveillance).

Related services

More services

services-1

Registration of medical devices

services-1

Clinical Trials

services-1

Quality management systems for medical devices

services-1

Simplified registration

services-1

Checking medical equipment

services-1

Expedited product registration

services-1

Simplified registration

services-1

Checking medical equipment

services-1

Expedited product registration

prem-1
8 years

on the market as a Company

prem-2
802 projects

successfully completed projects

prem-1
223 clients

customers from foreign countries

prem-1
70% clients

foreign clients with AR services

Ready to start
cooperation?

Fill out the form and we will contact you as soon as possible to discuss cooperation