Growing Public Healthcare Support by IAF and the New ISO 13485:2016
By Grant Ramaley (Dental Trade Alliance)
Every patient in the world deserves safe and effective care when they go to the doctor. Taking care of seven billion patients is a shared responsibility among tens of thousands of medical device manufacturers worldwide. Everything from gene-altering devices used to cure cancer to root canal fillings; they all play a critical role in our well-being and sometimes our survival.
Since 1996, Medical Device Regulators and industry have been working with and refining the quality system standard ISO 13485. The purpose of each refinement is to improve healthcare worldwide. Twenty years later, more countries have adopted this standard for regulatory purposes. There is even a “Playbook” created by medical device regulators that advocates use of 13485 when developing a regulatory system.
