ISO 13485 is the international standard for medical device quality management systems and details the requirements needed for regulatory purposes. Being ISO 13485 certified demonstrates that you meet a robust and recognised quality system of working practices. This can add significant value to your business and also attract customers. Based in Blackpool, Lancashire, Patient Guard Ltd can set up a QMS to this standard for your organisation and, if necessary, maintain the system on your behalf. If you are interested in this service please contact our ISO 13485 standard consultants today.
Internal audits are to be carried out as part of the requirements of ISO 13485. They are a review of the SOPs and practices carried out that ensures the business is performing in line with the procedures mentioned in the QMS. It is a very good tool for reviewing processes and procedures and making them more streamlined and efficient, therefore improving business efficiency. Patient Guard Ltd would be happy to carry out internal audits at your organisation or train your staff to become internal auditors.
When making a change to your medical device, it is important that it is captured and documented to make a history of the design, known as a 'design history file'. The details of any change should also be noted in the medical device’s [technical file]. It is important that the changes agreed upon form part of your risk management for the device; that any significant changes are detailed to the [notified body] (if not a Class I device); and that all necessary validation/verification is carried out to ensure safety. The consultants at Patient Guard Ltd can help you to review your design change process and offer advice on what actions will need to be carried out for the design change to occur.