Innov & Dev 2

Quality

ASDM is dedicated to delivering products and services of a high quality that are delivered on time, which meet and exceed the requirements and expectations of our customers and regulators.  Quality is the foundation upon which we design, manufacture, distribute our products for sale.  We meet these quality objectives through the implementation of a comprehensive quality management system, which is continually monitored for effectiveness and improvement.

The quality management system (QMS) at ASDM is governed, implemented and maintained in accordance with the US FDA Code of Federal Regulations 21CFR Part 820, ISO 13485: 2003 Medical Devices Quality Management Systems standard and the European Medical Devices Directive 93/42/EEC.  The primary objective of the quality management system is to ensure compliance with these standards and regulations and as a result ensure the safety and efficacy of all products that are supplied by ASDM.