REGULATORY COMPLIANCE
- Technical File
- Post-Market Surveillance
- Clinical Evaluation
- Usability Engineering
- Biological Evaluation
- Risk Management
- Accompanying Documents
MEDICAL DEVICE PRODUCT PORTFOLIO PRIORITIZATION
- For companies with large medical device portfolio under development/transitioning to MDR
- Revision of preliminary clinical evidence, State of The Art and Technical Documentation status for selection of candidates closer to meeting MDR requirements for CE-mark
QUALITY MANAGEMENT SERVICES
- ISO 9001:2015 — Establish, implement, maintain and document
- ISO 13485:2016 — Establish, implement, maintain and document
- ISO 14001:2015 — Establish, implement, maintain and document
R&D PROJECT MANAGEMENT
- Project Management of Medical Device Designs
- Generation of the Comprehensive Design Input
- Identification of Intended Purpose and Classification
STATISTICAL DATA ANALYSIS AND INTERPRETATION
- Clinical Investigation Data Analysis
- Post-Market Clinical Follow-Up Data Analysis
- Data Transfer to Clinical Evaluation and Periodic Safety Update Reports
SUSTAINABILITY
- Sustainability Development Goals
- Circular Economy and Sustainable Engineering
LIFE-CYCLE MANAGEMENT IN MEDICAL DEVICES
- Supply Chain Management
- Disposal of Medical Devices
TRAINING
- Design Control Training
- Human Factors Training
- IEC 62366-1 Application of Usability Engineering to Medical Devices
- IEC 60601 Medical Electrical Equipment: General Requirements for Basic Safety and Essential Performance
- ISO 9001 Quality Management System
- ISO 13485 Quality Management System
- ISO 14001 Quality Management System
- ISO 11135 Ethylene Oxide Sterilization Validation
- ISO 10993: 1-20 Biocompatibility Testing for Medical Devices
- ISO 14971 and IEC 60812 Risk Management
- MDD to MDR Transition
- Technical Documentation for CE Marking of Medical Devices
- MDR Requirements for CE Marking of Medical Devices
- MDR Implementation for CE Marking of Medical Devices
- Post-market Surveillance System Implementation
- Clinical Evaluation Reporting for Medical Devices
- Process Validation for Medical Devices
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