Revised ISO standard on GCP for medtech trials ushers major changes
This article was originally published in RAJ Devices
Executive Summary
The much-awaited, revised international standard on good clinical practice requirements for medtech clinical investigations has been published by the International Organization for Standardization1,2.
You may also be interested in...
Canada Boosts Postmarket Device Safety With New Reporting Rules
Device companies operating in Canada are being advised to review their internal procedures in anticipation of new postmarket requirements that come into force this year.
Global Regulators Seek Unified Approach To Remote Inspections
Remote inspections are here to stay, and global regulators are aligning efforts to develop consensus on how these should be conducted.
Canada Proposes 14 New Entries To List Of Recognized Device Standards
The Canadian medtech regulator has recommended updating its list of recognized medical device standards that manufacturers can rely on to demonstrate compliance with local safety, effectiveness and labeling requirements.
Need a specific report? 1000+ reports available
Buy Reports