ISO 13485 & MDR 2017/745
Our Services
Comprehensive services we offer in medical device regulation
ISO 13485 Quality Management System
Quality management system setup, internal audit, and certification support for medical device manufacturers.
Quality management system setup
Gap analysis and improvement
Internal audit services
Certification preparation
Process documentation
MDR 2017/745 Compliance Consultancy
Full compliance with the European Union Medical Device Regulation.
Regulatory assessment
Compliance roadmap
Technical file preparation
UDI system integration
EUDAMED registration support
Technical File Preparation
Preparation of all technical documentation required for CE marking.
Device description and specification
Design and manufacturing information
Essential requirements checklist
Labeling and instructions for use
Biocompatibility assessment
Clinical Evaluation
Clinical evaluation reports, PMCF plans, and clinical investigation support.
Clinical Evaluation Report (CER)
Clinical evaluation plan
PMCF plan and report
Literature research
Clinical investigation protocol
Risk Management (ISO 14971)
Establishing comprehensive risk management processes for medical devices.
Risk management plan
Hazard analysis (FMEA)
Risk assessment report
Benefit-risk analysis
Post-market surveillance
Training & Seminars
In-house and open training on medical device regulation.
MDR 2017/745 training
ISO 13485 internal auditor training
Risk management training
Clinical evaluation training
Customized in-house training