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.

Funding
SPRING 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:
  1. Medical Device Specification Developers
  2. Medical Device Manufacturers (Product Owners)
  3. Medical Device Contract Manufacturers and Precision Engineering Companies that is moving into Medical Technology industry intending to become Product Owner(s)
  4. Companies intending to convert from ISO 13485:2003 to ISO 13485:2016

Eligibility

SMEs
  • 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
Start-Ups
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”
Scope of Work

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