Novosys Pte Ltd, Singapore (Novosys)

ISO 13485:2016 – Quality Management System for Medical Devices

ISO 13485 Singapore

Overview

ISO 13485 specifies requirements for a quality management system (QMS) specifically designed for organizations involved in the medical device industry. The standard outlines the criteria for the development, implementation, and maintenance of an effective quality management system to ensure compliance with regulatory requirements and the production of safe and effective medical devices.

Funding Availability

Up to *50% Funding available for the third-party consultancy fee by Enterprise Development Grant (EDG).
Being Certified Project Management Consultants, we are recognized by Enterprise Singapore to defray up to *50% of the project cost through the EDG program if you engage us now!

Competitive Advantages of ISO 13485:2016

  • Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
  • Increase access to more markets worldwide with certification
  • Meet regulatory requirements and customer expectations
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices

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Process Flow

Initial
Consultation

Our consultant will contact you to gather information about your organization to understand your company needs and ISO standard requirements.

Gap Analysis and Planning

Assess your organization’s current practices and identify gaps. Develop a plan to address the gaps and achieve ISO compliance.

Documentation and Implementation

Develop necessary documentation, policies, and procedures. Implement the changes and new processes within your organization.

Training and Awareness

Provide training to employees on ISO standard requirements and their roles in the implementation.

Internal Audits

Conduct internal audits to assess the effectiveness of the implemented ISO management system and identify areas for improvement.

Certification Audit and Issuance

Receive the ISO certification, upon successful audit from an accredited certification body.

Consultancy

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