ISO 9001:2015

“The ISO 9001:2015 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.”

ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.”

MDD 93/42/EEC

MDD 93/42/EEC

Amongst many other objectives, this directive is established to ensure that: "... medical devices must provide patients, users and third parties with a high level of protection and achieve the performances assigned by the manufacturer ..."
 

PED 2014/68/EU

PED 2014/68/EU

This Directive has been created with several objectives in order to ensure devices including: "... that certain pressure equipment, although subjected to a maximum allowable pressure PS greater than 0.5 bar, does not present significant risks due to Pressure ... »