Quality and regulatory
VR-series products are designed and made by Van Roon Medische Techniek B.V. in Leiden. We act for the manufacturer in the UK and Ireland.
Quality management
Our quality management system is certified to ISO 13485:2016 for the sale, installation, servicing and repair of hospital beds and patient-support surfaces. The certificate is available on request from vigilance@vanroon.uk. The manufacturer’s own quality management system covers design and manufacture.
Our role for the manufacturer
Van Roon Medical UK Ltd is the manufacturer’s UK Responsible Person for VR-series products placed on the market in Great Britain, and its importer and distributor in the UK and Ireland. In that role we keep the technical documentation available, cooperate with the authorities on any request about the products, and handle complaints and incident reports.
VR-series beds and surfaces are Class I medical devices. Each carries the CE marking and, for Great Britain, the UKCA marking. Declarations of conformity are in the document library.
Reporting an incident
If a Van Roon product has been involved in an incident or a near miss, or you think it may have caused or contributed to harm:
- Make the patient and the area safe, and take the product out of use. Label it “Do not use” and keep it, with any accessories, as it is. Do not clean, repair or return it until we have agreed with you how it will be examined.
- Tell us as soon as you can: call the service desk on 0808 157 0614 or email vigilance@vanroon.uk with the product, serial number, date and a short description. Do not include patient names or other identifying details.
- Report it through your hospital’s incident reporting procedure and to your national reporting system.
We acknowledge every report on the next working day. Where the manufacturer needs to examine a product, we collect it and lend a replacement. We send you the findings in writing.
Customer notices
When the manufacturer decides that hospitals need to act, we send a field safety notice to the named contact at every hospital with the products concerned and publish it on our customer notices page. We follow up until every hospital has acknowledged it.
Complaints
Complaints about our products or service can be made to any member of staff or to info@vanroon.uk. We acknowledge them within two working days and aim to give a full answer within 20 working days.