Quality assured

TeleMedCare is committed to providing innovative telehealth products and services of consistently high quality, reliability and value. We achieve this through a highly qualified team of professionals applying proven international standards of quality management from design and development through to manufacture and support. We continually work with regulatory authorities to maintain high standards of quality assurance and regulatory compliance.

We have achieved and maintain the following certifications for our health monitoring systems:

  • Australian Therapeutic Administration (TGA) product quality assurance conformity assessment certificate AU Q00178. All products are registered as class IIa medical devices on the Australian register of therapeutic devices.
  • European Product Quality Assurance CE certificate, MRA Q00056 for conformity with annex VI of the European Council directive 93/42/EEC for class IIa medical devices.
  • TUV SUD America and Health Canada ISO 13485:2003 quality management system certification for the design, development, manufacture, distribution and service provision of telehealth monitors – multi-parameter, ISO and CMDCAS certificate  S 951 11 4818.

These credentials together with our Food and Drug Administration (FDA) 510k No. K103796 clearance to market TeleMedCare health monitors in the United States of America as class II medical device

assure the safety and effectiveness of our product.

 


 

TeleMedCare Pty Ltd

Phone: (+61) (0)2 9313 1836
Fax: (+61) (0) 2 9313 8564

Email: contact@telemedcare.com.au

Suite 7, Level 1
6-8 Crewe Place
Rosebery NSW 2018
AUSTRALIA