Herga Technology renews ISO 13485:2016 and ISO 9001:2015 accreditations

Herga Technology, the UK designer and manufacturer of switching and sensing solutions has successfully
completed independent renewal of its ISO 13485:2016 and ISO 9001:2015 quality management

Through a challenging four day audit in June an extensive assessment ensured that Herga’s
quality management systems – which are rigorously applied across all aspects of its business – fully
meet the statutory and regulatory standards that ensure it sustainably delivers the high quality
medical and industrial grade footswitches and hand controls required by its valued customers. The
ISO 13485:2016 medical standards complement individual IEC/UL 60601 approvals for medical
grade switching and sensing products. With ongoing annual reviews, these renewed accreditations
will run until 2022.
Paul K Edwards, Herga’s Head of Engineering & Quality commented, “Team belief, commitment,
consistency and hard work has meant Herga successfully renewed its certification again this year.
Without this our customers would not have the confidence in our design and manufacturing
Herga’s technical and production teams work closely with its quality management staff, together
providing a strong focus on continuous improvement for existing product production techniques
and performance enhancements. New product development is tracked by a comprehensive project
gate process that ensures quality, costs and timescales are optimised from concept through to
launch, complete with planned life-cycle support.
Herga Technology’s comprehensive product range covers standard and customised single- or
multi-pedal switches in ergonomic designs that span electrical/electronic, pneumatic, Bluetooth®
and USB switching technologies. With a strong emphasis on the extremely high standards and
competitive costs required to maintain its market leading position, Herga’s product range is widely
specified for switching and sensing tasks in medical device equipment, industrial equipment,
business and domestic machines, and many other demanding footswitch and hand control