CamNtech is delighted to announce compliance with ISO13485:2003 and EN ISO13485:2012.
As part of our ongoing commitment to quality, CamNtech has implemented a Quality Management System meeting the requirements of ISO13485:2003 and EN ISO13485:2012. Following the successful audit by the Notified Body, SGS UK Ltd, the certification was issued on 1st May 2014.
Our existing certification to the Medical Devices Directive 93/42/EEC for product quality assurance continues as before.
Medical devices must be appropriately designed, manufactured, tested and validated against a number of international standards for risk management, safety and performance. CamNtech shall be annually audited for compliance with the Standards and Directives and are also subject to un-announced audits following the recent revisions to the regulations.
Where some manufacturers choose to ignore the regulations, we strive to provide the highest level of quality assurance to our customers for our products and services. This ultimately leads to a safer device and reliable performance whether in clinical or research applications.
Please visit our certification area for full details of our worldwide regulatory compliance.