Quality Management System
Uncompromising Quality. Globally Certified Precision.
At Racer Medical, quality is not a department. It is our culture.
We leverage state-of-the-art inspection technology and rigorous regulatory frameworks to ensure every medical device meets the highest standards of safety and efficacy.
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, and cutting errors, hence building better partnership with our partners.
Our Integrated Quality Systems
Proven Processes
Our quality assurance division utilizes state-of-the-art measuring equipment to inspect critical dimensions, ensuring every product strictly adheres to customer specifications.
Statistical Precision
We employ advanced tools to maintain zero-defect standards, including:
Process Validation (IQ/OQ/PQ) and Design & Process FMEA.
SPC Tools: Process Capability Studies (Cp/Cpk), Control Charts (X-Rbar), and Pareto Charts
Low Rejection Rates
We implement inspection, testing, and validation procedures at every stage of the manufacturing cycle.
Continuous Process Improvement
We do not just fix errors; we identify and eliminate their root causes. Any rejection triggers an immediate investigation and process optimization based on data analysis and feedback loops.
Regulatory Compliance
All facilities undergo regular reviews to ensure they meet international ISO and FDA standards.
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.
LEAN Principles
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.
KANBAN Methodology
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.
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.
Certifications & Recognition
ISO 9001:2015
Quality Management System(certified since 1998)
ISO 13485:2016
Medical Device Quality Management System(certified since 2005)
ISO 14001:2015
Environmental Management System(certified since 2006)
UL Facility Code: HJ431
FDA Establishment Registration
(Registration No. 97060)
GMP-compliant operations and Six Sigma methodologies
COVID-19 Resilience Certification
(2023)
P&G Partners Award
(2019)
Singapore SME 1000 Companies
(2012)
Singapore Outstanding Enterprise Award
(2012)
Singapore Brands Award
(2012, 2013)
Singapore Excellence Award
(2011, 2013)
Good Performance Award from Six Sigma Singapore
(2010)
Good Quality Award from Six Sigma Singapore
(2011)
(2000)
Ecosystem and Collaboration
Singapore MedTech Consortium
We play a pivotal role in building the industry's research base and leveraging advanced 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.
