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. […]

We warmly welcome our new colleague Lisa Lundberg Dellenvall in joining the QA&RA consultant team. Lisa has a Master’s degree in Chemistry and brings a wealth of experience from the international medical device industry. In particular, she is very well versed to bring clarity and stability in potentially complex design control processes. Further, her expertise […]