Understand about the ISO certification for Medical devices

Understand about the ISO certification for Medical devices

A company really needs the ISO 13485 certification that is used to describe the Quality management system. This certification demonstrates that the company is able to provide medical devices and services.

Such organisations may be involved in one or more stages of the life cycle, such as design and development, storage and distribution, production, installation, or servicing of a medical device, as well as design and development or provision of matching operations. ISO 13485 can also be utilised by suppliers or third-party vendors who provide product-related services to such entities, such as the Quality management system.

Except as specified, iso 13485 singapore Certification criteria apply to all enterprises, regardless of size or kind. Where standards for medical devices are mentioned, the rules also apply to associated services provided by the organisation.

The ISO 13485 required procedures that are applicable to the organisation but are not carried out by the organisation are the organization’s function and are accounted for in the organization’s quality management system by maintaining, managing, and monitoring the processes.

If applicable regulatory requirements allow for the removal of design and development controls, this makes to take decision for removing from the quality management system. These management requirements may necessitate the use of various strategies that comes within quality management system.  It is the organization’s responsibility to ensure that any reduction of design and development controls is reflected in claims of conformance to iso 13485 singapore Certification.

ISO 13485 certification benefits:

ISO 13485 Certification will help you improve overall operations, decrease ambiguity, and boost market opportunities, whether you want to operate worldwide or locally. Companies that have earned this certification have demonstrated a commitment to quality to both customers and controller.

  • Provide access to worldwide market location
  • Excellent source to improve the process within your company
  • Improve efficiency, reduce expenses, and gain control over supply chain operations.
  • Demonstrate that your medical devices are safer and more effective.
  • Meet safety requirements with customer expectations.



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