In order to comply with statutory requirements, all manufacturers must have a quality management system (QMS). We prepare all process descriptions, templates for work instructions and other forms you need to set up a QMS, and can help you with the control of quality documents and records.
According to the EU Medical Devices Regulation (MDR), medical device manufacturers of all risk classes are required by law to set up a QMS within their companies. Do you lack the capacity to set up a QMS, or do you need additional support?
We can draw on our experience working with firms of all sizes to prepare a QM documentation to suit your company. This will ensure you remain compliant with all MDR requirements as well as safeguarding and improving the quality of your products, systems and processes.
EN ISO 13485
A quality management system (QMS) is designed to ensure that the quality of systems, processes and products is regularly inspected and improved within your company. The EN ISO 13485 standard describes the requirements for quality management systems for medical device manufacturers.
We can provide you with assistance on your premises, and compile the documentation you need to get through the certification process.