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 2016 version of...
I am working with a very interesting company (at Delta Consulting Alliance, we never release names of our clients) that wants and needs our services, but wants them “step by step”. You might be thinking, oh, they’re not the brightest crayons in the box, but this is not the case! I...