Medical Device Consulting

  • GEMAR

Project Management

  Prior art search and non infringement studies

  Invention disclosure

  Voice of the Customer methodology (VOC)

  Users Requirements Analysis to define Uses Specifications

  Device System and Sub-system analysis

  Risks Management

  Prototyping

  CMC and Laboratory Testing

  Project Management fulfilling Medical Devices Regulations:

  Design Control and DHF filing

  Definition of Regulatory Affairs data from Design

 

(Non) Clinical Studies

  Clinical Investigation Study Design and Protocol Development

  Clinical Investigation Management for Medical Devices

  Clinical Evaluation Reports and Literature Review for Registered Medical Devices

  Clinical Consulting

 

Regulatory Affaires

  Global Regulatory Consulting for Drugs, Medical Device and IVD Companies

  Registration and Approval

  Regulatory Consulting

  Regulatory Gap Analysis

  Testing Strategy

  Creation of a Regulatory Dossier

  Global Drugs, Medical Device Registration and Medical Device Approval

  European Representative service

  US agent service

 

Quality System

  Development of Quality Management System

  ISO 13485 and US FDA QSR Consulting and Certification for Drugs and Medical Device Manufacturers

  Implementation of Pre-production Quality Management System

 

  GMP and Quality System audits 

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