OUR SERVICES

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

LIFE-CYCLE MANAGEMENT IN MEDICAL DEVICES

  • Supply Chain Management

  • Disposal of Medical Devices

SUSTAINABILITY

  • Sustainable Development Goals

  • Circular Economy and Sustainable Engineering

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