17 Apr

13485:2016—Beyond the Risk Management File

13485:2016—Beyond the Risk Management File

James A. Dunning • Principal, QPC Services LLC Many companies currently are transitioning from ISO 13485:2003 to ISO 13485:2016, the updated standard drafted to help medtech firms evolve with the industry and address changes in the underlying ISO 9001 benchmark. Some companies, however, are finding it difficult to understand the additional requirements imposed by the […]