Reports and Services as per MEDDEV 2.7.1 Rev 4:2016

Medzus consultancy of Clinical Evaluation & Clinical investigation in medical device helps manufacturer to maintain & supporting regulatory records to obtain high ethics value to the products.

Medzus follows various harmonised standards and delivers quality services through our highly competent technical expertise. Medzus adheres to widely accepted writing practices and follows GCP while preparing clinical evaluation report according to MEDDEV requirements.

Activity and Services we offer through Medzus Consulting:

Guidance on MDR 2017/745 requirement

MEDDEV Vigilance; system setup and control

Clinical Evaluation/Clinical Investigation; Documentation, Development of protocol/procedure

Record and maintain; clinical data/AE/Clinical evaluation/Clinical performance and safety

Residual Risk as per ISO 14971; GAP Analysis and Risk Management

IFU warnings and Contraindications

Post Market Surveillance (PMS) & Post Market Clinical Follow Up (PMCF); Process and Plans

Clinical Trials if required

Data from predicate / equivalent device; Demonstration

Stages of Clinical Evaluation

Stage - 0:

Define the scope, plan the clinical evaluation

Stage - 1:

Identification of Pertienent Data

Sources of data/documentation used in a clinical evaluation.

Data Generation through Literature Search

Data generated and held by - Vigilance/ PMS/PMCF in line with Risk Management & Essential Requirements.

Stage - 2:

Appraisal of pertinent data.

Stage - 3:

Analysis of the clinical data.

Stage - 4:

Preparation of Clinical Evaluation Report

For Complete quote or detailed proposal.

Write to us on:info@medzushealth.com or mail@medzushealth.com

Checklist for Clinical Evaluation Report Source Documents Requirement from Sponsor