Hi, I am looking for advice on BS EN 62304:2006 Medical devices software – Software life-cycle processes. The company I work for create embedded software for a medical device manufacturer. I have been tasked with finding out how we gain certification to BS EN 62304:2006. From research carried out so far I have found very varied information; from you can’t be certified to it to a company that will carry out the certification as long as they carry out your ISO 13485 certification. We are currently certified to ISO 9001, ISO 27001 and ISO 13485 but our certification body do not cover BS EN 62304. Any advice gratefully accepted.