Grow With Us
ARQon Headquarters is now at:
Singapore Manufacturing Federation building
A tool to classify a medical device
- ASEAN Registration
- CE Rep with ARQon
ARQon has a GLOBAL team coming from various medical industries and regulatory authorities. Being receptive to local regulatory changes, we provide the best submission strategies for our clients.
ARQon provides competitive costing as compared to other global consultants.
Free and Accurate Resources
ARQon offers free and accurate resources to use. Please check out the links from our registration pages below by clicking on the respective countries.
ARQon responds to any of your enquiries within short notice. We do not like to keep a client waiting.
ARQ®-10MDQ "10 Questions for Medical Device Regulations and Answers" for the countries is available.
Please contact us.
Check out our event page for the latest training and updates. In-house training customisation is available for the industry, authority, and institution.
Quality Management System
QMS applies to manufacturers involved in design, manufacturing, and the distribution of ISO 13485, US QSR, GMP, MDSAP, GDPMD.
Product Registration may be complicated depending on each country's requirements and classification, but we can register and be the country representative for your product.
Manufacturers must meet the design control requirements and build Design History File (DHF) for all classes with the exception certain Class 1 device.
Regulatory Management System
Let us manage and support your Regulatory department for a regional role, and with the expedition of projects. The right team, strategy, and software can create a Good Regulatory Management System environment.