Emma FortinUnderstanding the CAPA Quality ProcessCorrective and Preventive Actions (CAPA) are the cornerstone of quality management and are essential for sustaining product excellence…Jun 29, 2023Jun 29, 2023
Emma FortinClass II Medical Device Development Document Organization: A Guide to Effective Quality ManagementAn organized Quality Management System (QMS) that ensures compliance and makes effective document management possible is necessary while…Jun 26, 2023Jun 26, 2023
Emma FortinKey Requirements for Medical Device Developers in the Canadian MarketAre you a medical device developer looking to enter the Canadian market?Jun 19, 2023Jun 19, 2023
Emma FortinEssential Steps for Preparing for Your First FDA and MDR AuditPreparing for your first FDA and MDR audit can be a challenging task for any medical device company. The audit process plays a crucial role…Jun 14, 2023Jun 14, 2023
Emma FortinEffective Implementation of CAPA in Quality Management SystemsCorrective and Preventive Action (CAPA) is a crucial process within quality management systems that aims to identify, investigate, and…Jun 8, 2023Jun 8, 2023
Emma FortinUnveiling the Importance of Post-Market Surveillance in Medical Device IndustryAs a blogger and QMS consultant in the medical device industry, it is important to understand the value of post-market surveillance. After…May 31, 2023May 31, 2023
Emma FortinEvaluating qmsWrapper: A Cut Above the CompetitionAs a seasoned QMS consultant, I have had the privilege of working closely with clients who utilize various software solutions to manage…May 22, 2023May 22, 2023
Emma FortinComplying with 21 CFR Part 11: Why qmsWrapper is the Best Solution for Medical Device ManufacturersWith the growing complexity of medical devices and the increasing need for patient safety, medical device manufacturers are required to…Mar 24, 2023Mar 24, 2023
Emma FortinHow to choose QMS software for your company?Market is crazy and everybody is racing to stand out from the crowd — we know this. But did you know that invention is not dead? I’m…Dec 6, 2022Dec 6, 2022
Emma FortinqmsWrapper Set of Templates: SOPs and Workflow ProcessesBy purchasing a qmsWrapper license, you get a set of SOP Templates and Workflow Processes, prepared to accommodate the standards: ISO 13485…Sep 30, 2022Sep 30, 2022
