ISO 13485:2016 conformance

ISO 13485:2016 conformance


TensCare Ltd is and has been ISO EN 13485:2016 certified since 2019 and conformed to ISO 13485 since 2015. We constantly undergo auditing processes and reviews by BSI, who thoroughly assessed our quality management systems and safety procedures in application for ISO EN 13485:2016 certification. 

What is ISO EN 13485?

ISO 13485 is an international standard of Quality Management Systems (QMS) for companies involved in the manufacture of medical devices. The latest version of the standard has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.

TENS, EMS, IFT, and MIC units are medical devices and therefore should be supplied with the correct safety requirements set out by European Commission.

ISO accreditation demonstrates a commitment to quality in manufacturing and business processes to ensure customer safety and product reliability. It demonstrates the consistent design, development, production, and delivery of medical devices that are safe for their intended purpose.


What are the benefits of ISO EN 13485?

  • Accreditation means easier access into more global markets
  • Improved efficiency and safety in workplace procedures
  • Cost savings through supply chain management
  • More effective risk management and quality assurance for the manufacture of safe medical devices
  • Better able to respond to customer requirements and meet customer expectations


What does it mean for suppliers?

Buyers should not be simply satisfied with EN 60601 safety certification but should enquire that their supplier is ISO EN 13485:2016 accredited to be sure that they are receiving medical devices which have been appropriately safety tested.

Failure to do this can leave them open to liability of using or supplying on to their customers medical devices that are not assured to be safe.

TensCare's ISO 13485:2016 accreditation assures suppliers that we meet all current safety standards and business practises.


What does it mean for customers?

Customers can be rest assured that TensCare's products go through rigid safety procedures and testing for the upmost assurance when it comes customer safety. This demonstrates TensCare can produce safer and more effective products.

Our improved feedback processes ensure that customer satisfaction is of upmost importance.

If you would like more information regarding ISO EN 13485:2016, please see the ISO website.



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