Entries by Johnnie Dahlberg

Christmas Rhyme 2nd Advent

Management responsibility (ISO 13485:2016 clause 5) The second of advent is coming up have the Elves managed the IT-backup? Santa is stressed and the deadlines fills his mind, the final QMS-approval need to be signed. His Company is a Legal Manufacture, and they need sufficient infrastructure. Quality objectives, regulations and software tool, so the CEO […]

Christmas Rhyme 1st Advent

Design and development (ISO 13485:2016 clause 7.3) Christmas is coming and today is advent, but Santa and his Elves are not ready yet. Is the processes deemed sufficient and good, or can anything be totally misunderstood? Design Control is almost the trickiest part, Santa and his Elves need to be talent and smart. To ensure they […]

New guidance for medical devices
by Health Canada

Health Canada has issued guidance on summary reports to implement a lifecycle approach to the regulation of medical devices in Canada. Health Canada has issued a guidance on Summary reports and issue-related analyses for medical devices to help medical device manufacturers comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulation. […]