ARQon (Asia Regulatory & Quality Consultancy) Pvte. Ltd. of Singapore at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
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ARQon (Asia Regulatory & Quality Consultancy) Pvte. Ltd.

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

Hall map

MEDICA 2017 hall map (Hall 16): stand G58

Fairground map

MEDICA 2017 fairground map: Hall 16

Contact

May Ng

Director

Phone
+65 6687 2982

Email
info@arq-on.com

Our range of products

Product categories

  • 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

Company news

Date

Topic

Download

Sep 7, 2017

ARQon Speaks in MEDICA CONNECTED HEALTHCARE FORUM

Ms. May Ng, Director from ARQon will be speaking in MEDICA CONNECTED HEALTHCARE FORUM  on the topic of "Are All Connected Devices Controlled as Medical Devices? "

Come join us in this insightful talk, the details as follow:
      Date: Thursday, 16 November 2017
      Time: 11:50 am – 12:15 pm
      Venue: Hall 15, Stand 15C24
      Session: 8

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About us

Company details

ARQon is a regulatory consultancy for medical devices, IVD's 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 team consists of professionals with broad product category experiences in medical device and drug manufacturing sites, trading industry, ex-regulators from Singapore Health Sciences Authority and trainer for Asia and ASEAN regulators. 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

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Company data

Sales volume

1-9 Mio US $

Number of employees

20-49

Foundation

2014

Area of business

Medical Services and Publications