Description
MDR Compliance System
As you are probably well aware, the Medicines and Healthcare products Regulatory Agency (MHRA) has been increasing inspections on manufacturers recently. Would you be ready for an inspection if you were chosen?
Do not leave it to chance that you will not be inspected!
Let the Dental Laboratories Association (DLA) make it easy for you to ensure your business stays abreast of the MDR requirements.
All information provided in the package comes ready for you to implement and use.
What the system includes:
Medical Devices Regulations Manual – this contains procedures that establish what happens in your laboratory. Once you have read and updated the contents, this document should only need updating occasionally, for example in the instance of any operational changes.
Medical Devices Regulations Log Book – unlike the procedures manual, this log book will be used daily to record various activities such as purchasing and maintenance. Depending on the size of your laboratory you may wish to split this log book into separate parts for ease of use.
Medical Devices Regulations Checklist – you will need to complete this to help implement the system.
