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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
- 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