Medical Devices Regulatory Convergence Through ISO 13485

Thirty or more years ago, each regulator used to set its own QMS rules. But, in the early 1990´s manufacturers and regulators realized that standardizing those rules would benefit stakeholders including patients, users, manufacturers and regulators. Several of those efforts resulted in the creation of ISO 13485 in 1996. This standard has become the best way to achieve global regulatory convergence.