Our Global Partners

Global Expertise

Brazil

Contact Person:

Mr. Eduardo G. Monteiro

eduardo@egmont.com.br

Expertise:

  • Submissions to ANVISA
  • CE marking
  • Quality System Certification

Belgium

Contact Person:

  • Mr. Gideon Elkayam
  • gideon@obelis.net

Expertise:

  • EU Representation
  • CE Marking
  • EU Product Registration
  • Technical Documentation and EU submissions
  • EU Consultancy and Training
  • Founders of MDLaw – a comprehensive platform made available to industry for all MDR and IVDR information

Canada

Contact Person:

  • Mr. Paul Bassler
  • paul.bassler@pasb.ca

Expertise:

  • Medical Device Quality Assurance & Regulatory Affairs
  • Environmental Regulatory Compliance
  • Engineering Support

China

Contact Person:

  • Mr. Eric Fan
  • fanwenqian@zhixie.info

Expertise:

  • Founder of the largest database of medical device products and enterprise information in China
  • Medical Device submissions to NMPA
  • Market access in China and Distributor appointment
  • Assistance with promotions and website content

Egypt

Contact Person:

  • Mr.Ahmed Shahean
  • ashahean@ietqan.com

Expertise:

  • Medical Device testing and validation
  • Quality Management systems, Training and auditing
  • CE technical file preparation
  • In -country Regulatory submissions
  • Regulatory training

GCC and Middle East

Contact Person:

  • Mr. Hamed Jamal
  • hjamal@racs-me.com

Expertise:

  • Quality Conformity Assessment Body and Certifications to:

    • ECAS
    • EQM
    • HALAL National Mark
    • SASO
    • G Mark

India

Contact Person:

  • Mr. Sanjah Y Shah
  • sanjay@unikalindia.com

Expertise:

  • Quality Management System ISO13485 and ISO9001
  • CE certification
  • Device Master Preparation
  • Selection of Certifying/ Notified Bodies
  • Audit, Documentation and GMP

Netherlands

Contact Person:

  • Mrs. Daniëlle Motta
  • globalreg@Qservegroup.com

Expertise:

  • Regulatory Affairs
  • Quality Assurance
  • Training
  • Clinical Trials

Pakistan

Contact Person:

  • Mr. Razah Shah
  • razashah8@gmail.com

Expertise:

  • Regulatory Affairs
  • Quality Management Systems
  • Environmental Management System
  • Social Compliance Services