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.