isoFTI Awarded ISO 9001 & ISO 13485 Certifications & Certificate for Medical Devices Directive 93/42/EEC

FTI are delighted to announce that they have been awarded ISO 9001:2008 – Quality Management System Certification, ISO 13485:2003 – Medical Devices Certification and Medical Devices Directive 93/42/EEC. The audit was passed with no minor or major non-conformances reported – a substantial achievement.

Scope of Certification

Standard(s) Scope
ISO 9001:2008
Quality Management System Certification
Design, manufacture and supply of pressure equipment and instrumentation and related training services
ISO 13485:2003
Medical Devices Certification
Design, manufacture and supply of pressure regulator for inhaled nitric oxide
Medical Devices Directive 93/42/EEC Pressure regulator for inhaled nitric oxide therapy

In meeting the requirements of the accreditation FTI has demonstrated that it has the following in place:

• Structure and systems to support the implementation, stability, effectiveness and maintenance of the Quality Management System (QMS).

• Structure and systems to ensure the continual development of its QMS.

• Monitoring and tracking progress of key objectives and targets.

“I am very proud of this achievement it is a major milestone in the development of FTI. It is testimony to the effort and commitment of all the staff at FTI and the award of these certifications strengthen the platform of our business and the total commitment to our vision for the future and our company values.”

Andrew Parker (Director)

Click here to view the official ISO/CE Certificates