OUR SERVICES

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

LIFE-CYCLE MANAGEMENT IN MEDICAL DEVICES

• Supply Chain Management

• Disposal of Medical Devices

• 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