Regulatory Pathway Development

  • Identification of the applicable laws and standards
  • Identification of the registration sequence for different countries in the world
  • Definition of the most appropriate conformity assessment procedure
  • Realization of the Quality Plan including required validations prior to market introduction
  • Deployment of methods to address specific requirement in the Quality Management System
  • Communication with Regulatory Bodies and Competent Authorities

USA Regulatory Pathway

  • Classification of the device
  • Determination of Pre-Market Approval vs. 510k approaches
  • Preparation of Investigational Device Exemption file
  • Setup of a QSR compliant Quality Management System

Middle East and Asian 
Regulatory Pathways

We maintain a knowledge database of the regulatory procedures for various countries such as :

  • Far East including Thailand, Taiwan, Malaysia, Singapore
  • Middle East including Israel, Jordan, Iran, Irak, Saudi-Arabia, Egypt, UAE, Lebanon 
  • Classification of the device

CE Regulatory Pathway

  • Identification of the applicable medical directives (MDD, AIMDD, IVDD)
  • Determination of interfaces with Machine, Low Power and Personal Protective Directives
  • Development  and implementation of a Quality Management System 
  • Choice of conformity assessment route
  • Planning and managing of submissions
  • Identification of a capable Notified Body

Regulatory Pathway

  • Classification of the device as per applicable acts and regulations
  • Use of CE mark to support conformity assessment for Australia
  • Integration of chapter 4 of the Therapeutic Goods Act 1989 and of the Therapeutic Goods (Medical Devices) Regulations 2002
  • Preparation of conformity assessment certification forms
  • Design of the technical file