- Quality System -

Continuous Process Improvement 

We are constantly improving our processes to keep up with stringent manufacturing demands and breakthrough innovation in the MedTech industry. Harnessing the power of LEAN and KANBAN methodologies, we empower businesses to streamline operations, reduce waste, and achieve operational excellence.



  1. LEAN Principles: We are committed to the fundamental principles of LEAN, focusing on the elimination of waste, continuous improvement, and respect for people. Our experts work closely with your team to identify inefficiencies and implement sustainable solutions that optimise your processes.
  2. KANBAN Methodology: Leveraging the visual and adaptive KANBAN approach, we help organisations visualise workflow, manage work in progress, and achieve a smooth, just-in-time production flow. This results in improved communication, reduced lead times, and increased overall productivity.


The adaptive nature of our processes allows our organisation to quickly respond to changes in demand, market conditions, and internal dynamics, fostering agility and resilience. As a result, we managed to Double our labour productivity | Cut production throughput time | Reduce inventories by 90 percent | Cutting errors , hence building better partnership with our partners.


The Singapore MedTech Consortium also plays a pivotal role in working to build the research base that helps the Singapore’s MedTech industry leverage its own supply management. To adopt systems approach, we need to constantly discover with updated technology and entities that are both up and down the value chain. By understanding products better, we can help all the aspects in Validation Protocol.

Our Quality Systems 


Proven processes with our quality systems, Racer’s quality assurance division is equipped with state-of-the-art measuring equipment capable of inspecting critical dimensions for assurance that our products adhere to customer’s specifications. All parts and its processes are controlled with a Quality Inspection Plan. Advanced statistical process techniques such as Process Validation/IOQP, Design & Process FMEA and others SPC tools like Process Capability Studies (Cp/Cpk), Control Charts (X-Rbar) and Pareto Charts are also engaged.

Successful system implementation: 

  • ISO 9001:2015 Quality Management System certified since 1998.
  • ISO 13485:2016 Medical Device Quality Management System certified since 2005.
  • ISO 14001:2015 Environment Management System certified since 2006.
  • FDA Establishment Registration: 9710609.
  • UL Code: H1431
  • GMP & 6 sigma procedures


Manufacturing Awards: 

  • COVID-19 Resilience Certification , Awarded in 2023
  • P&G Partners Award 2019
  • Singapore SME top 1000 Companies 2012
  • Good Performance 2010 from Siix Singapore
  • Good Quality 2011 from Siix Singapore
  • Supplier Excellence 2000, from Seagate
  • Singapore Outstanding Enterprise Award 2012
  • Singapore Brands Award 2012/2013
  • Singapore Excellence Award 2011/2013

Global Regulatory Framework

As part of our ongoing commitment with our customers, we are able to provide regulatory advice to aid our customers in selling their products to their desired market. This is a tedious process as each country has different regulations (E.g., FDA, CE Marking, HSA, AFTA).


Key Challenges: Regulatory Divergence, Language and Cultural Barriers, Resource and Capacity Gap in some regulatory bodies, Market Protectionism


Take for example the Asia market, every product needs to be duly approved by each individual regulatory authority in every Asia country. Therefore, ASEAN countries came up with the “ASEAN Guidelines for Harmonisation of Standards”. This is adopted by all ASEAN member states, to complement ASEAN Free Trade Area (AFTA). In particular, to eliminate technical barriers, but without compromising product quality, efficacy, and safety.