Quality Validation & GxP in the Medical Device filed
Medical Devices are being used to treat, diagnose, and cure, and as a result, pose a high risk to patients. This is the main reason why the medical device industry is characterized by stringent levels of supervision and regulation. The main target of the Quality Management System, SOPs training, verification and validations, is to maintain public health while minimizing the chance and risk of harm to human life
Quality Validation & GxP consulting services in the medical device filed
Quality Management System
ISO 13485 certification
Medical device design control
Risk analysis and risk assessment based on ISO 14971
DMR- Device Maser Record
Design History File
Compliance with FDA, ISO, CE, GxP regulations
Technical file
Quality system training and courses
Risk Assessments and risk analysis training
Cleaning and sterilization validation
ISO 27001, ISO 27799 and ISO 14001 certification
Pre-audit, gap analysis & training towards FDA/NB inspection
- Preparation for FDA, CE, ISO quality tests and reviews
Manufacturing and assembly process controls
Validation & Verification (V&V)
Software & ERP system 21CFR part 11 & Annex 11 validation
Validation for medical cellular applications
Validation for cleaning and manufacturing processes
Cleaning & disinfection for Multi-use Medical Device
Validation and quality improvement project management
- Validation for sterilization and sterilization
- Validation for clean rooms
Validation for packing and transporting based on ASTM D4169, ISO 11607, ASTMD 7368
Validation training and courses
Bio-compatibility materials
CE marking, MDD, MDR
Suppliers and contractors quality inspections and audits
Policies and procedures writing and training
Other medical device services