About Us
AQS Labs provides training workshops for all medical device industry professionals (individual, institutional and corporate) in Singapore. Interested professionals outside of Singapore are welcome to join us. These workshops are designed based on extensive hands-on experiences working with various levels of professionals at multinational companies and small & medium-sized enterprises (SMEs) in southeast Asia since 2010. The workshops are led by Mr. Vincent Cheung, a seasoned industry practitioner with more than twenty-five (25) years of direct experience in the commercialization of medical device products including design control, risk analysis, process validations, root cause investigations, supplier management, and other quality system processes required by 21 CFR Part 820, ISO 14971, and ISO 13485. Each workshop is delivered in two (2) successive days with a maximum of twenty (20) people participating in interactive activities using common industry practices, equipment, software, and tools that are essential in the commercialization of medical devices. All workshops are registered online on a “first-come, first-served” basis and conducted onsite at AQS Labs.
Services
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 (QSR), ISO 13485, ISO 14971, IEC 62304, and IEC 62366 for product design, 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 EN ISO 13485:2016 quality management system certifications, FDA quality system inspections, 510(k) clearance, and CE Mark. The range of medical products include:
  • Single-use (sterile) devices
  • Implantable devices (non-active)
  • Electrical medical equipment
  • IVD assays
  • Surgical instruments
  • Software as a medical device (SaMD)
AQS is founded by Mr. Vincent Cheung, an industry practitioner with more than twenty-five (25) years of combined medical device design, 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.