A successful implementation will demonstrate a company’s ability to supply Medical Devices and related services to customers that comply with regulatory requirements ISO 13485 is not just products focused, but it focuses instead on the processes, used to develop Medical Devices. Keep in mind that you also need to comply with all relevant product and service-oriented technical standards and regulations in this area of expertise. Although ISO 13485 is based on ISO 9001 Quality Management Standard and uses the same numbering system. ISO 13485 doesn’t include the ISO 9001 requirements related to continual improvement and customer satisfaction ISO 13485 also focuses more on how procedures regulate and control activity and process performance. Read More..