Racer Technology is one of the leading medical manufacturers in Singapore Medtech Industry. We are established since December 1988 & specialise in manufacturing high quality & regulatory compliant medical devices. Our group has a staff strength of about 2,000 members based regionally and occupy 300,000 square feet of manufacturing space. With our corporate headquarters in Singapore & sales office in California, supported by ISO certified manufacturing facilities in Indonesia (Batam) & Malaysia (Senai) you could enjoy significant cost savings with uncompromising quality assurance.
Through a systemic understanding of the requirements & target feasibility experiments, our engineering experience allow us to streamline & Identify improvement of flaws during our product design development, which contributes to high productivity & process consistency. Our disciplined approach to systems engineering, programmatic risk management & detailed design minimize the development & manufacturing risk, optimize projects budget & accurate market launch date.
Singapore Medtech Consortium,
Racer Technology is spearheading the SG Medtech Consortium (SMC) to forge collaborations to stay competitive in todays Medical Manufacturing market. The Singapore Medtech Consortium is a group of Singapore-based companies from Venture Capitalist, Manufacturers & Distributors. We provide end-to-end manufacturing solutions in the areas of in-vitro diagnostics, wearables and life science tool consumables. We are able to offer high mix low volume manufacturing to medtech companies at a competitive cost, assist in early-stage product development, customise solutions in design thinking and provide efficient manufacturing and box build assembly.
Our task in providing world class quality components, involved from our top management, down to our delivery men.
Quality System Accreditation: -
• ISO 9001:2015 Quality Management System ~ TÜV-SÜD-PSB Pte. Ltd.
• ISO 13485:2016 / EN ISO 13485:2016 Medical Device Quality Management System~ SGS United Kingdom
• ISO 14001:2015 Environment Management System ~ TÜV-SÜD-PSB Pte. Ltd.
• FDA Establishment Registration Facility (9710609).
• UL (Underwriter Laboratory) Recognised (H1431).
• GMPs & LEAN 6 Sigma.
Our Medical Industry expertise includes:-
• Product Design and Development
• Low cost Prototyping tooling for proof of concept
• DFMEA & DFM review prior to tooling fabrication, Design Optimization.
• Regulatory Product Certification (CE, FCC, IC, CCC, ETL, IECEE)
• Class 100,000 Cleanroom facilities in molding & Assembly.
• 2 shots molding, reel to reel molding, structural molding, In-Mold Decoration (IMD)
• Process qualification & validation capabilities.
• Intellectual Property Protection (IPP)
· Reagent dispensing, fusing & packaging service.
• PCB Assembly, SMT-BGA, Micro BGA, Component Size 0201, Manual Insert Assembly, Rework Station, Conformal Coating.
• In Vitro Diagnostic Device (IVD) dispensing & filling
Kindly refer to our Website link below for our profile: