Tag: COTS MES

The publication of the ISO 13485:2016 standard in March of this year realizes work that began in July 2014 with the rejection of the first Draft International Standard (DIS)

Taking the time to do proper risk management, identifying and mitigating risks, can protect the organization from unnecessary costs and heartache. In this post, you will find key risk factors that you must understand in both approaches to ensure a smooth path to implementation.