Helena Dahlin is working as a consultant at Key2Compliance® and has a broad experience from working in an international environment.
Helena has an extensive knowledge about Medical Devices and the Post market process, and the need for a thorough Quality process. She is well experienced on the Medical Device industry on such as ISO 13485, MDD 93/42/EEC, MEDDEV2.12-1 guideline and 21 CFR 820.
Helena has been working as Product and Quality Manager at Kibi, and as Project Manager at St. Jude Medical in developing Quality- and Post Market Software systems.