CONSTRUCTION OF TECHNICAL FILES FOR MEDICAL DEVICES IN ACCORDANCE
WITH EUROPEAN MEDICAL DEVICE REGULATIONS MDR 2017/745 AS WELL AS
MEDICAL DEVICE DIRECTIVE MDD 93/42/EEC;
INTERNATIONAL QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES EN ISO
13485:2016/AC:2018, AND ISO 9001:2015;
AWARENESS AND BASIC INFORMATION CONCERNING THE ENVIROMENTAL
HEALTH AND SAFETY SYSTEM;
INTERNATIONAL STANDARD FOR BIOLOGICAL SAFETY FOR MEDICAL DEVICES
ISO 10993-SERIES,
FULL PRACTICE (ESTABLISHMENT OF STUDY STRATEGY, DOCUMENTING
PROTOCOL AND ISSUING STUDY REPORT) ON MANY INTERNATIONAL
STANDARDS RELATED TO MEDICAL DEVICE INDUSTRIES AS WELL AS
PHARMACEUTICAL PRODUCTS
ACCELERATED AGING STABILITY, AND REAL TIME STABILITY TESTING
FOR MEDICAL DEVICES AND PHARMA PRODUCTS
PACKAGING, STERILIZATION “EO, STEAM, GAMMA”, BIOBURDEN,
SHIPMENT, AREA QUALIFICATION, PROCESS VALIATION,
CHEMICAL SAFETY AND BIOCOMPATIBILITY COMPLIANCE AS PER ISO
10993-SERIES, AND REACH REGULATIONS.
PRODUCT QUALIFICATION FOR “BLOODLINES, DIALYZERS, FISTULA
NEEDLES, HEMODIALYSIS CONCENTRATED SOLUTIONS,
HEMOFILTERS, BACTERIAL AND ENDOTOXIN RETENTION FILTERS,
INFUSION SET, TRANSFUSION SETS, IRRIGATION SETS, DIALYSIS
CLEANING CARTRIDGES, BICARBONATE CONTAINERS, HEPARIN
SODIUM INJECTION, INTRAVENOUS SOLUTIONS, BICARBONATE
SACHETS;
INVOLVEMENT IN QUALITY PROJECTS WITH REGARDS TO SIX SIGMA, 5S, LEAN
MANUFACTURING, DFSS (DESIGN FOR SIX SEGMA), ROOT CAUSE ANALYSIS, PFMEA
AND FMECA, FTA, HACCAP, FISHBONE DIAGRAM FOR PROBLEM SOLVING;
GOOD MANUFACTURING PRACTICE;
CE MARKING; MDSAP (MEDICAL DEVICE SINGLE AUDIT PROGRAM)
