Beat Steffen invited as Speaker for Seminar regarding ISO 13485:2016 at Swiss Association for Standardization (SNV)
After some hefty discussions during the final stage of the development, the latest edition of ISO 13485 was published in March of this year. As most have meanwhile realized, it’s more of an evolution than a revolution. Anyway, it’s a step in the right direction and enables manufacturers and service providers to both comply and demonstrate their compliance to regulatory requirements. The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device.