Service

ARQon (Asia Regulatory & Quality Consultancy)

67, Ayer Rajah Crescent, #02-08 , 139950 Singapore
Singapore

Telephone +65 66872982
info@arq-on.com

This company is co-exhibitor of
Singapore Manufacturing Federation

Trade fair hall

  • Hall 16 / G58
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 16): stand G58

Fairground map

MEDICA 2016 fairground map: Hall 16

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

About us

Company details

ARQon is a regulatory consultancy for medical devices and drug companies. We assist our clients in aspects of regulatory and quality from development to product registration submission to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World. Our range of clients includes researchers, manufacturers and traders from both start-ups and MNCs.

Services offered:

1)    Registration

ASIA – Australia TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN – Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS – Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE – Notified Bodies Approval
MIDDLE EAST – Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals

2)    Development - Design History File (DHF), Technical File
3)    QMS – US FDA QSR, GDPMD/S, MDSAP, ISO 13485
4)    RMS (Regulatory Management System) - SOP
5)    Distributor Search and Distributing
6)    Clinical Trial Plan and Conduct, Clinical Evaluation
7)    Manufacturing Plant Set-up and Process Validation
8)    Training

More Less

Company data

Sales volume

1-9 Mio US $

Number of employees

20-49

Foundation

2014

Area of business
  • Electromedical equipment / Medical Technology
  • Laboratory Equipment
  • Diagnostics
  • Physiotherapy / Orthopaedic Technology
  • Commodities and Consumer Good for Surgeries and Hospitals
  • Information and Communication Technology
  • Medical Services and Publications