Medical Technology
Quality Management System(QMS) for MedTech Industry – ISO 13485:2016
This is a Collaborative Industry Project (CIP), supported by SPRING Singapore that aims to help SMEs and start-ups who are product owners of medical devices to achieve ISO 13485 certification. Adopting ISO 13485 helps companies meet the comprehensiverequirements for a quality management system (QMS) which is the foundation to meeting global regulations and demonstrating a commitment to safety and quality of medical devices. The programme is designed and managed by industry practitioners with demonstrated track records. It provides hands-on training and consultancy services to help companies understand, implement or remediate their QMS within the ISO 13485:2016 framework and build in-house regulatory expertise. The time frame for project completion is estimated to be between 6 to 12 months. FundingSPRING Singapore will provide funding of up to 70% of the programme fee. Only Small-Medium-Enterprise (SME) and/or Start-Ups can qualify for the funding. Programme fee varies depending on required scope and approval. Who Can Apply:
Applicable to Small-Medium-Enterprises/ Start-Ups as follows:
- Medical Device Specification Developers
- Medical Device Manufacturers (Product Owners)
- Medical Device Contract Manufacturers and Precision Engineering Companies that is moving into Medical Technology industry intending to become Product Owner(s)
- Companies intending to convert from ISO 13485:2003 to ISO 13485:2016
- Registered and Incorporated in Singapore
- Minimum 30% local shareholding by Singapore Citizens or PRs
- Have an annual sales turnover (at group level) of not more than $100 million or employment size not exceeding 200 employees
Registered and Incorporated in Singapore not more than 5 years ago
Important: This programme is not applicable to Medical Devices Distributor/Reseller. Project Deliverables
- QMS Implementation deliverables: “Documentation of quality management policies, procedures, quality manuals”
- Training Deliverables: “Application-based training of key staff
- Successful ISO 13485:2016 quality management system recommendation letter issued by audit/notified body
- Provision and submission of “Regulatory pathway/roadmap”


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