Do You Need ISO 13485 Certification?
ISO 13485 is an internationally recognized quality management standard specifically for the medical device industry. It provides a framework for an effective quality management system (QMS) and can be used by any organization that designs, develops, manufactures, or distributes medical devices in Europe. This standard is particularly applicable to organizations that are in the medical device supply chain. ISO 13485 certification is ideal for these businesses: Medical device manufacturers If you manufacture medical devices or any components or sub-assemblies for medical devices, then you will need to comply with the requirements of ISO 13485. This standard will help you to control your design and manufacturing processes so that you can consistently produce safe and effective medical devices. Pharmaceutical companies If you are involved in the manufacture of pharmaceuticals, then you will need to comply with the requirements of ISO 13485. This standard will help you to con...