TensCare Ltd receives ISO Certification 13485 -- MEDICA - World Forum for Medicine


TensCare Ltd.

TensCare Ltd receives ISO Certification 13485

ISO 13485 Certification

We are delighted to announce that TensCare Ltd are ISO EN 13485: 2012 certified.

TensCare Ltd constantly undergo auditing processes and reviews, the most recent of which was conducted by Intertek, who thoroughly assessed our quality management systems and safety procedures in application for ISO EN 13485 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.

TENS and EMS units are medical devices and therefore should be supplied with the correct safety requirements set out by EC directives.

ISO accreditation demonstrates a commitment to quality manufacturing and business processes to ensure customer safety and product reliability.

What are the benefits if ISO EN 13485?

Creditation 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 accredited to be sure that they are receiving correctly safety tested medical devices.

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 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.

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

If you would like to learn more about TensCare's products, visit us on stand 11 H41 or contact us for more information.