ISO Certification: ISO 13485: 2016 |

ISO Certification: ISO 13485: 2016

We credit our success with our ability to develop and maintain a cutting-edge product portfolio, which continues to meet and exceed the expectations of the end user. TensCare Ltd constantly undergoes auditing processes and reviews every year, the most recent of which was conducted by LRQA, who thoroughly assessed our quality management systems and safety procedures in application for ISO EN 13485 certification.

We are proud to inform you TensCare Ltd’s Management and Quality Systems are have successfully been accredited with ISO 13485: 2016 certified.

What is ISO EN 13485?

You may be wondering what ISO 13485 is? ISO 13485 is an international standard of Quality Management Systems (QMS) for companies involved in the manufacture of medical devices. This ensures that the product we have produced meets EU consumer health and safety requirements and our products are registered with many World Health Regulatory Authorities and Government Ministries of Health around the World. 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 a liability of using or supplying on to their customer's 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 practices. 

What does it mean for customers?

Customers can rest assured that TensCare's products go through rigid safety procedures and testing for the upmost assurance when it comes customer safety.

Customer safely lies at the heart of TensCare. Your safely and user experience is our number one priority. 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