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.
Assures the clients that the product complies with all relevant product & service-oriented technical standards & regulations.
Emphasizes the cleanliness & sterility in the production area which in turn increases efficiency & enhances safety at the workplace.