Standard
ISO 13485 certification in Singapore
ISO 13485 is the quality-management standard for medical-device design and manufacture. In Singapore it is the expected credential for MedTech makers and their suppliers, and it aligns with the Health Sciences Authority (HSA) regulatory regime. Current version: ISO 13485:2016.
Seen most in Biomedical & Medtech Manufacturing . Common among Medical device manufacturing services .
What it is
A QMS tailored to medical devices — risk management, traceability, sterility and design controls beyond ISO 9001.
Who needs it in Singapore
MedTech manufacturers, contract manufacturers, and precision suppliers making device components or implants.
How to get it
Certification by an accredited body; frequently paired with HSA product registration and, for export, EU MDR / US FDA QSR alignment.
Companies on the record holding ISO 13485
- Beyonics
A contract precision-engineering and turnkey manufacturer machining to 8 µm positional accuracy and 4 µm repeatability in aluminium, magnesium and specialty alloys from a Marsiling plant. A dedicated metal-tooling division builds injection moulds — sequential, stack, 2K, insert and unscrew — progressive dies and precision gears on Makino, Charmilles and Sodick machines with CMM, for parts from 15 to 1,600 tonnes clamping and walls below 0.18 mm. ISO 9001, IATF 16949, ISO 13485, ISO 14001 and ISO 45001; serves MedTech, mobility, semiconductor and automotive.
Website (opens Beyonics in a new tab) - Flex (Singapore)
One of the world's largest EMS providers, Singapore-incorporated with a long-established local presence. Design and management sit in Singapore, while high-volume PCBA is predominantly offshore across its low-cost footprint in Malaysia and China. Its Flex Medical unit runs regulated medical-device and drug-delivery manufacturing.
Website (opens Flex (Singapore) in a new tab) - Grand Venture Technology
An SGX Main Board precision group whose sheet-metal fabrication — laser cutting, CNC bending, turret punching, robotic MIG welding and paint and powder finishing — sits alongside precision machining and cleanroom assembly for the semiconductor, life-sciences, aerospace and medical sectors. Around 1,717 staff; ISO 9001, ISO 13485 and AS9100D certified.
Website (opens Grand Venture Technology in a new tab) - Jabil (Singapore)
The Singapore plant of the US-parent EMS major, offering full PCBA, assembly and supply-chain services from its Tampines site serving regional customers. Its Jabil Healthcare / Nypro unit runs ISO 13485 lines and cleanroom device assembly and packaging for OEM medical and diagnostic customers.
Website (opens Jabil (Singapore) in a new tab) - MAP Plastics
A MedTech-focused maker of high-precision tools and injection-moulded medical components, running 60+ moulding machines and a 10,000-class cleanroom. The company states output of around two billion medical components a year. Certified ISO 13485, ISO 9001, ISO 14001 and ISO 14064.
Website (opens MAP Plastics in a new tab) - Meiban Group
A vertically integrated electronics manufacturing services group with in-house mould making — mould design, precision injection moulding, PCBA and full product assembly across Singapore, Malaysia and China. Runs Class 100K cleanrooms and additive-manufactured conformal-cooling tooling. ISO 9001 and ISO 13485 certified.
Website (opens Meiban Group in a new tab) - SP Manufacturing
SP Manufacturing is a privately held, Singapore-headquartered electronics manufacturing services (EMS) provider building wire harnesses, box builds and printed circuit board assemblies for mission-critical aerospace, automotive, medical, industrial and semiconductor customers. It runs plants and offices in seven countries — Singapore, Malaysia, Indonesia, China, Germany, Poland and the US — and holds ISO 13485, IATF 16949 and AS9100D.