![]() ![]() It ensures the consistent design, development, production, installation, and delivery through to the disposal of medical devices that are safe for their intended purpose. The ISO 13485 certification supports medical device manufacturers in plotting a QMS that creates and maintains the efficacy of their processes. ISO 13485 is a stand-alone Quality Management System standard for medical devices, obtained from the globally acknowledged and accepted ISO 9000 QMS series. Although changes in your QMS will take immediate additional energy, the results of having an ISO 13485 quality management system will provide you with many benefits in operations, sales, and customer satisfaction. Implementing ISO 13485 will have many benefits for your organization. However, the certification gives assurance to the people that quality happens at every stage of manufacturing which enables maintaining a high standard for medical devices. The ISO 13485 certification does not spell out the specific measures for medical device manufacturers. All with the aim of maintaining quality and safety and most importantly meeting compliance. Special rules, standards, regulations, and certifications are either applicable or required for the medical devices industry. ![]()
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