ISO 13485 – Medical Devices

ISO 13485 Certification (Medical fraternity)

ISO 13485 is the ISO for the medical fraternity. ISO 13485 is a worldwide QMS (Quality Management System) certification for medical device which helps prove important compliances.

Who is it relevant to?

All requirements of the ISO 13485:2003 standard are specific to organizations providing medical devices, regardless of the type or size.

Question: Why take ISO 13485 certification?

• Risk management leads to increased patient and user safety.
• More business in domestic / global markets and also helps in getting big hospitals tenders, government tenders etc.
• ISO 13485 is currently recognized in most major markets worldwide and is a prerequisite for companied dealing in medical and biomedical products.
• ISO 13485 certification demonstrates that the process are in place to produce safe and effective medical device.
• While ISO 9001 demonstrates continual improvement ISO 13485 demonstrates that the quality system is implemented and maintained.
• Its implementation helps identify potential hazards and implement control measures to minimize the likely hood of any non conformity.
• It helps to build confidence in your prospective clients and gives trust and value to your business partners.