By: Steve McCarthy, DIRECTOR OF REGULATORY AFFAIRS, email
Dell Tech attended the Medtech Canada 2024 Regulatory & Quality conference in Ottawa at the end of April.
This hybrid event marked the first in-person Medtech Canada conference since 2019 and it was excellent to once again share the room speaking with Health Canada representatives and networking with industry colleagues.
Health Canada opened their updates with an introduction by acting Directory General, Bruce Randall, and over the two days delivered presentations on: the significant change guidance document, eSTAR and the regulatory enrollment process, MDSAP, establishment licensing, compliance program, and pre-marketing screening and review.
Continue watching this space as Dell Tech provides more details on the 2024 Medical Device Directorate’s key policy initiatives and issues that are front of mind for industry.
Through its acquisition of McCarthy Consultant Services Dell Tech Laboratories now offers our clients medical device regulatory affairs and quality services. If you need help with the risk classification of your device, submitting a device license or device establishment license application, developing, and implementing a quality management system, support with Health Canada inspection or any other medical device related assistance contact Dell Tech to speak with our team.
Dell Tech has provided professional, confidential consulting services to the specialty chemical
industry in Canada, the USA, Europe, and Asia for the last 40 years.
