Quality Standards


Patient’s safety is the core focus of Envaste and to ensure this, we are committed to provide both quality products and services. The healthcare industry is heavily regulated and at Envaste, we ensure that we are fully compliant with all required standards. We take pride in the level of compliance we achieve and this is valued by both our physician customers and healthcare medical device manufacturers.
 

As Patient safety is the focus of Envaste, we commit to provide high quality products and services. Our Quality Management offers technical knowledge, experience and excellent service to our customers. The expert knowledge of our employees converges in cross functional teams for product innovation. We harness this expertise through the creation of working groups to continue to develop and improve our Quality Management System.


Envaste complies with the following QUALITY standards:
 

  • BS EN ISO 9001 : 2008
  • BS EN ISO 13485 : 2003
  • BS EN ISO 11137-1 : 2007
  • FDA rules 21 CFR part 820