ISO 13485

ISO 13485: Medical Devices Quality Management SYstem


The ISO 13485 standard concerns manufacturers and suppliers of medical devices.

ISO 13485 is the most accepted standard worldwide for manufacturers of medical. The standard is based on ISO 9001 but includes additional requirements specific to this business sector. In addition, important terms have been defined including medical device, active medical device, active implanted medical device, sterile medical device, and many more.

A certificate issued by an independent accredited certification body guarantees that a quality management system has been implemented, documented, used, maintained, and improved by the supplier or manufacturer of medical devices.

ISO 13485 supports the reduction of unexpected risks with regard to the devices and enhances their management. This applies not only to companies that construct, produce and service medical devices but also to organizations distributing and using them. The standard aims to increase the organization’s reputation in the eyes of customers and authorities.

Getting ISO 13485 Certification

  • Please click here to request a callback or further information on how you can become ISO 13485 certified. We can also provide a no-obligation competitive quotation from our dedicated business development team.
  • Our leading auditors will devise a comprehensive assessment program that will be agreed upon in line with your requirements.

Certification Benefits

  • Eligibility for submitting tenders or proposals for projects.
  • Evidence of adherence to legal and regulatory or contractual requirements
  • Generates new business opportunities
  • Can boost your organization’s brand reputation and be a useful promotional tool, especially when going up against competitors who aren’t certified
  • Guarantees high quality of provided services and products
  • Reduces production loss rate
  • Reduces operational costs
  • Increases effectiveness across the whole organization
  • Increases your customers‘ trust in you as a safe supplier or producer
  • Minimize corporate risk

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