ISO 13485 Implementation

According to new MDR and IVDR regulations, all manufacturers should have a Quality Management System in place, the scope of which is proportionate to the risk class and type of product concerned. The implementation of ISO 13485 ensures that the quality system complies with current legal requirements.

What are the legal requirements for a Quality Management System?

In the new MDR and IVDR regulations, all manufacturers should have a quality management system in place to ensure that mass-produced products comply with the legal requirements, which should be proportionate to the risk class and type of product concerned. The Quality Management System should be established, documented, implemented, maintained, constantly updated and systematically improved. The system should cover all parts and elements of the manufacturer’s organisation dealing with the quality of processes, procedures and products, and manage the structure, responsibilities, procedures, processes and resources within the company.

How can we help?

When deciding to implement the ISO 13485 standard, you may consider using a consultant to help you with the implementation process. The right choice of ISO 13485 consultant is a solution that will significantly increase your chances of success and shorten the time to obtain certification. If you decide to implement ISO 13485 under the guidance of MDR Regulator, you can be sure that the quality management system will be tailored to your business.