An Easy Transition
The Client
Huntleigh Healthcare Ltd. are a leading provider of innovative and high quality medical equipment for healthcare professionals. They are based in Cardiff and are a member of the Arjo family, specialising in handheld Doppler products for vascular and Foetal monitoring. In this field, the demand for clinical excellence is high, and complete confidence in this equipment is essential to make sure that patient wellbeing remains the top priority.
The Challenge
When Huntleigh first approached Collocco, they were adjusting to a change from the Medical Device Directive 93/42/EEC to the Medical Device Regulation 2017/745. This meant that Huntleigh’s quality management system required an update to ensure that it was compliant with this new regulation in order to support ongoing supply to the market.
Updating existing systems to comply with new regulations isn’t a quick fix. Balancing the rollout of the updates to the Quality Management system along with the training can be difficult whilst maintaining business-as-usual. Huntleigh needed a solution that would be efficient and effective so that they could continue to provide the high quality medical equipment to their customers without disruption.
The Solution
Collocco helped the Huntleigh team to review their current Quality Management system and identify exactly where the updates were required in order for them to remain compliant with Medical Device Regulation 2017/745. Collocco supported Huntleigh with the planning and roll out of these changes in order to ensure ongoing product supply. Collocco also delivered tailored training to make sure everyone in the team was confident in the updated Quality Management System. The Project was completed with a successful external audit outcome.
Here’s what they had to say…
“Working with Jill at Collocco Consultancy was a pleasure. Amending the Quality Management System at Huntleigh Healthcare Ltd. to accommodate the Medical Device regulation 2017/745, delivering training and assisting with Technical files updates was never going to be an easy task. With Jill's help on this matter the transition seemed relatively easy”.
– Steve Monks, Director QRE Compliance at Huntleigh Healthcare Ltd
