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ISO 13485 Medical Devices Consultancy in Singapore
Established in Singapore in 1992, CCIS has helped many organisations achieve ISO, Singapore Standards (SS) and bizSAFE certification, as well as other compliance goals.
EDGE Eligible under Enterprise Singapore’s EDGE Grant (Sector-specific)
- 1992Established in Singapore
- 30+Years of management systems expertise
- 20,000+Companies served
- S$400KPaid-up capital in Singapore
What is ISO 13485?
ISO 13485 is the international standard for quality management systems for medical devices. It covers design, production, storage, distribution, installation and servicing, with particular emphasis on risk management, traceability and regulatory requirements.
How CCIS helps you achieve ISO 13485 certification
- Gap analysisWe assess your current practices against ISO 13485:2016 and the regulatory requirements for your devices
- Scope and risk managementWe guide you in defining the scope of the system and applying risk management across the product life cycle
- System designWe guide your team in developing the procedures and records required by ISO 13485 and your regulatory obligations
- Implementation and awareness trainingWe train your team on how to implement the system and apply it in daily operations
- Internal audit and management reviewCCIS conducts the internal audit to confirm readiness for certification and trains your team on how to conduct the management review
- Certification audit preparationWe prepare you for the independent certification body’s audit and advise on any findings
Optional maintenance support is available after certification, including help with surveillance and recertification audits.
Why organisations choose CCIS
- More than 30 years of consultancy experience in Singapore
- “Write what you do, do what you write”: a system your team understands and can maintain
- Able to integrate with GDPMDS and other standards for organisations that also distribute devices
- Integrated management systems since the 1990s, featured in the national newspaper in 1998 for a first-of-its-kind certified IMS in the region
ISO 13485 questions
Which organisations need ISO 13485?
Organisations that design, manufacture or supply medical devices, or provide related services, typically require ISO 13485 to meet regulatory and customer requirements.
Is ISO 13485 required in Singapore?
Medical device dealers are licensed by the Health Sciences Authority (HSA). Manufacturers are generally expected to hold ISO 13485 certification, while importers and wholesalers usually require GDPMDS (SS 620) certification. Please refer to HSA’s current requirements for your licence.
How does ISO 13485 differ from ISO 9001?
ISO 13485 is based on ISO 9001 but adds requirements specific to medical devices, including risk management, controls for sterile devices and regulatory reporting.
Can ISO 13485 be combined with GDPMDS?
Yes. Organisations that both manufacture and distribute devices often operate ISO 13485 and GDPMDS as one integrated system.
Is there government funding for ISO 13485?
Yes. ISO 13485 is supported under Enterprise Singapore’s EDGE Grant (Sector-specific), which can co-fund consultancy and first certification costs for eligible Singapore companies. Support levels and conditions are set by Enterprise Singapore, and the application must be approved before the project begins. CCIS can advise on eligibility before you commit.
Related medical device and quality services
Talk to an ISO 13485 consultant
Tell us about your devices and operations and we will recommend the right starting point for your ISO 13485 certification.
- Tell us about your organisationYour scope, sites and current practices
- We recommend a starting pointA gap analysis or a full certification project
- You receive a proposalIncluding EDGE Grant eligibility where it applies
Talk to our team
Tell us which standard, course or audit you require, and we will explain the steps and the support suited to your organisation.