ISO 9001:2000 (Certificate No. 493)
The award of this International Standard demonstrates compliance of our Quality Management System to the requirements of ISO 9001:2000 in all areas of Design, Manufacture and Servicing.

ISO 13485:2003 (Certificate No. 493B)
The award of this International Standard demonstrates compliance of our Medical Devices - Quality Management Systems - Requirements for regulatory purposes.

ISO 9001 is a generic quality system standard applicable to many industries. ISO 13485 is specific to medical device quality systems that supplement the ISO 9001 standard. Some of the additional requirements found in the medical device quality systems relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical devices industry.

MDD 93/42/EEC (Certificate No. 493CE)
The Medical Devices Directive, which is mandatory for all medical devices manufactured after the 14th June 1998, and is the European standard to which all such products must comply.

The Directive covers all aspects of product manufacturing, safety and performance.

Products that meet this Directive can feature this mark below: