ISO 13485 Providers
in Singapore

Find verified ISO 13485 Medical Devices Quality Management consultants, certification bodies, and training providers in Singapore. Compare profiles, read reviews, and get free quotes — no obligation.

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GQS
ISO Consultant
GQS

Singapore

GQS Singapore is a leading ISO consultancy firm which has provided approved lead auditor trainings, ISO certification consultant and support in various standards such as bizSAFE Level 1, bizSAFE STAR Certification SOC 1 Finance audit for a specified time period, SOC 2 Entire Info sec process, SOC 3 (Public report)- Type 1 (for a specified time) & Type 2 (over a specified period) Reporting PCI DSS Payment Certification HIPAA Health Insurance Portability and Accountability Act compliance audit Food safety modernisation Act FSMA by PCQI & FSPCA Approved Singapore consultant ISO 50001 Energy Management System ISO 55000 Asset Management AS 9110 Quality management for Maintenance repair and overhaul AS 9100 Quality Management for Aircraft parts manufacturing ISO 45001:2018 Occupational Health ISO 22000 Food safety management FSSC 22000 V 5.0 Food safety certification BRC British Retail Consortium ISO 13485 Management system for Medical devices ISO 17020 Accreditation R2 Responsible Recycling Version 3 R2v3 SERI Certification by SERI approved consultants. ISO 41001 Facility management system certification SMETA 6.0 SEDEX Audit SA 8000 Social Accountability ISO 22301 Business continuity management Certification SCAN Supplier Compliance Audit Network compliance audit support Responsible Business Alliance RBA audit support QC 080000 Hazardous Substances process management HSPM ISO 27001 & ISO 27791, Information security management certification & DPTM ISO 46001 Water efficiency management system certification IFS International Featured Standards Certification for Brokers, Manufacturers, Logistics. Data Protection TrustMark DPTM assessment Certification Consultancy Singapore based on the Four principles of Data such as Governance & Transparency; Management of Personal data, Care of personal data, Individual rights. SS 587 Singapore standards for End of Life for ICT equipment?s. CMMC 2.0 Cybersecurity Maturity Model Certification ESG Environment Social Governance GRI Reporting ISO 14064 Carbon footprint, validation GQS Singapore is a professional multi skilled consulting firm for all your ISO Certification needs.

ISO 13485ISO 14001ISO 27001

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Consultants, certification bodies, and training providers based in or serving Singapore

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About iso 13485 providers in singapore.

CertBetter lists verified ISO 13485 Medical Devices Quality Management providers based in or serving Singapore. Filter by service type (consultant, certification body, training), compare profiles and verified reviews, and submit a single free quote request to hear from multiple specialists simultaneously.

Not necessarily. Many ISO 13485 Medical Devices Quality Management consultants work remotely with clients worldwide and can deliver gap analysis, documentation, and training entirely online. However, a locally based consultant in Singapore may have an advantage for on-site work, regulatory familiarity, and surveillance audit support.

Total ISO 13485 Medical Devices Quality Management certification costs in Singapore typically range from $5,000 for a micro business to $60,000+ for a complex medium-sized organisation. This covers consultant fees (gap analysis, implementation, documentation, training) plus certification body audit fees (Stage 1 and Stage 2). Getting multiple quotes through CertBetter is the fastest way to benchmark pricing.

Most Singapore businesses complete first-time ISO 13485 Medical Devices Quality Management certification within 4–12 months. Organisations with existing documented processes and a dedicated internal lead move significantly faster — sometimes within 3 months. A gap analysis at the start is the best way to set a realistic and accurate timeline.

A ISO 13485 Medical Devices Quality Management consultant helps you prepare — conducting gap analysis, building documentation, training staff, and getting audit-ready. A certification body (CB) is an accredited organisation that independently audits your management system and issues the certificate. They are separate roles, and you typically work with both. CertBetter lists both types in Singapore.

Technically yes, but it is significantly harder and slower without expert guidance — especially for first-time certification. Most Singapore businesses that attempt self-certification take longer, face more audit non-conformances, and end up spending more overall. A consultant typically pays for themselves in time savings and reduced re-audit risk.