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
- 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.