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Quality Management System



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Regulatory Affairs





   

Regulatory Affairs

Quality Management System

Training

DMD Consulting provides regulatory compliance services regarding requirements of the US, Canadian and EU markets .

Companies located in Europe can benefit from local assistance with respect to US product submission requirements, particularly for implants, sterile devices or devices containing software.

Companies who wishes to marketing their medical devices in Europe can get assistance from DMD regarding EU CE marking requirements such as determining product classification, identifying an appropriate conformity assessment route to the CE mark, developing the Technical File, complying with post-market surveillance requirements and more.
 
Furthermore DMD can assist in selecting European Authorized Representative and setting up legal contracts regarding proper control of the authorized representative in compliance with the directives for medical devices and IVDs. 
 

US Product Submissions

European CE Marking

Product Classification

DMD Consulting provides compliance services regarding process -and software validation requirements of the US, Canadian and EU markets.
 
Process validation will be in accordance with the Global Harmonization Task Force guidance documents, FDA regulatory requirements and EU harmonized standards.

Software validation including Part 11 eRecords and eSignatures compliance will be in accordance with FDA guidance documents, FDA regulatory requirements and EU harmonized standards.

Quality Management System

DMD Consulting offers both open and closed training sessions.

Training courses are available in:

  • Software Validation,
  • Quality Management Systems (FDA QRS requirements
  • harmonized standard EN ISO 13485:2003)
  • Design Control requirements
  • CAPA (corrective and preventive actions)
  • EU Vigilance reporting requirements.
  • Risk management
  • Auditing sterile Medical Devices Manufactures
  • Establishing Compliance with the Medical Devices Directive.