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.
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
Define the scope, plan the clinical evaluation
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.
Appraisal of pertinent data.
Analysis of the clinical data.
Preparation of Clinical Evaluation Report
Device Name
2.Device Size (s)/Variant (s)
3.Device Description & Features
4.Classification of Device
5.Performance Claims
6.Material of Construction
7.IFU
8.Label
Product Specification
10.Certificate of Analysis
11.Design History Data
PMS Data
13.Sales Data (for 5 Years)
14.Complaints (If Any)
15.Product Recall (If Any)
16.Adverse Reaction (If Any)
17.Risk Management File
18.Biocompatibility Test Result with followed standards or guidelines
CE Status, NB
Product Catalogue/ Brochure
Product Website link
Company Logo (Use Authorization)