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 […]

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. […]