Promotes coordination of regulatory requirements for the manufacturers of medical devices on an international scale

Companies that attain ISO 13485 certification enjoy the benefits of an increased amount of customers who have more reason to trust and purchase consistent high-quality products.

ISO 13485 compliant management systems adopt a risk management approach which includes evaluation to identify & estimate risk, uses risk controls and techniques with a view to eradicating hazardous situations throughout product realization. iso 13485 certification