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Medical devices receive accreditation for design and manufacture

26th July 2016

Daisy Stapley-Bunten

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The UK designer and manufacturer of footswitches, hand controls and sensing solutions, Herga Technology, has recently received ISO 13485:2012 quality management system accreditation for the design, manufacture and related support services for the supply of medical devices. IEC 13485:2012 essentially specifies stringent procedures and requirements for Herga’s quality management system that allows it to demonstrate the ability to consistently provide medical grade footswitches and hand controls that meet customer’s requirements.

The accreditation follows a major structural transformation with extended investment in manufacturing systems and facilities since Herga Technology’s acquisition by the Variohm Holding Group in 2013. The changes have been cultural as well, with design, production and quality assurance staff all making a significant contribution for the new ISO accreditations.

Herga’s technical and production teams are strongly focused on continuous improvement with new product development tracked by a comprehensive project gate process that ensures quality, costs and timescales are optimised from concept through to launch with planned life-cycle support.

The new certification joins the recently awarded ISO 9001:2015 status as well as individual IEC/UL 60601 product approvals. The ISO 9001:2015 award places Herga Technology in the first 10% to receive the restructured certification which aims to ensure a consistent and common structure across ISO standards that will help provide more unified management systems for businesses and organisations. Herga is already working towards attaining ISO 13485:2016 and hopes to complete accreditation in 2017.

Herga’s comprehensive product range includes standard and customised single- or multi-pedal switches in ergonomic designs that are available with electrical/electronic, pneumatic, Bluetooth wireless and USB switching technologies. Application areas cover safe industrial, business and domestic machinery switching as well as medical grade switching and sensing.