Good record keeping is essential for the safe management of medical devices, and all aspects of medical device management require some degree of record keeping.
The detail and complexity of the records depend on the type of device and usage during its lifetime but it should include any specific information recommended in the legal manufacturer’s instructions, user guides and other supporting information. Records must be protected to ensure their accuracy is maintained and that any changes do not obscure previously recorded information.1
Arjo can offer a wide range of flexible service contracts to suit your requirements and budget, all designed to optimise the performance of your medical equipment and meet UK and Ireland compliance standards.
Reporting can also be included to provide effective asset management to achieve lean operational efficiencies.
Click below to find out more on how Arjo’s Aftermarket team can support your record keeping so you remain vigilant and maintain compliance in line with the relevant Regulations and Standards.
1. Managing Medical Devices Guidance for healthcare and social services organisations April 2015 - Medicines and Healthcare products Regulatory Agency (MHRA)