Applied Quality Systems Pte Ltd (AQS) is a Singapore-based consultancy
firm with extensive quality and regulatory industry experience in the
implementation, maintenance, and remediation of quality systems in accordance
with US 21 CFR Part 820 and ISO 13485 for product development, finished product and contract
manufacturing. AQS was established in 2010 and has a long track record in
helping organizations of different size and complexity successfully achieved
quality management system certifications, FDA quality system inspections, 510(k)
clearance, and CE Mark. The range of medical technologies includes:
Single use devices (disposable)
Implantable devices (non-active)
Electrical medical equipment
IVD assays
AQS is founded by Mr. Vincent Cheung, an industry practitioner with more than twenty
(20) years of combined medical device development, manufacturing, and technology
transfers experience in the US and Singapore. Mr. Cheung helps organizations
establish practical policies, robust quality system processes and procedures
based on hands-on experience in design controls, risk analysis, validations,
process controls, supplier quality, statistical analysis, internal audits,
and other quality system processes.