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Staying compliant with ISO 13485 is the first step in achieving regulatory compliance for medical device manufacturers.

Global standards are integral to fuelling continuous innovation that drives medical device technology. Hence, the ISO 13485 certification came into existence as a standard from the International Organisation for Standardisation designed to regulate QMS (quality management systems) of companies producing medical devices. ISO 13485 certification helps medical device companies meet the requirements for regulatory purposes and demonstrates these companies’ capacity to consistently meet customer needs. 

What is ISO 13485? 

ISO 13485 is a globally recognised medical device certification standard to help you demonstrate that your management system can meet product and regulatory requirements. The standard specifies requirements for a quality management system (QMS) to help an organisation show its ability to provide medical devices and related services that adhere to user and legal standards. Concerning IVD/Medical Device Companies, the ISO 13485 standard regulates the risk management approach to product realisation and development, validation of processes, efficient product traceability and recall system, statutory and regulatory compliance, process and product improvement. 

Who does ISO 13485 apply to? 

ISO 13485 extends to manufacturers of IVD’s and medical devices, suppliers, or any other external parties integral to the production process. It covers all the companies operating at any level in the IVD & medical device supply chain.

What are the benefits of being certified to ISO 13485? 

Certification follows successful completion of an audit and enables you to: 

  • Produce and distribute devices faster 
  • Enable systematic process improvement 
  • Discover ways to improve efficiency and add value 
  • Gain a competitive advantage 
  • Monitor supply chains for continuous improvement 
  • Contribute to UN Sustainable Development Goals: 3 - Good Health and Well-being and 10 - reduce inequalities.

How can SGS help? 

With expertise in all major industries, we understand each sector’s pain points and have the technical skills and logistical capabilities to ensure realistic outcomes. An audit against ISO 13485 from SGS will help your organisation to stand out from the crowd by supporting you to improve performance.  

In addition, we offer a range of training services:

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We are SGS – the world’s leading testing, inspection and certification company. We are recognised as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world