CharlesNavigating AI in QMS: Opportunities and Risks for Medical Device Companies in 2024Artificial intelligence is no longer a distant innovation; it’s actively transforming how Quality Management Systems function within the…16h ago16h ago
CharlesIs Greenlight Guru Really the Best Solution for MedDev Companies?When it comes to quality management software for medical device companies, Greenlight Guru has carved out a strong reputation in the…Oct 29Oct 29
CharlesNHS Digital Health Standards: Understanding DCB0129 and DCB0160With the increasing integration of digital health systems in the NHS, stringent standards have been established to ensure these…Jun 24Jun 24
CharlesValidating QMS Software for Medical Device CompaniesQMS software is crucial for medical device companies to ensure compliance with regulatory standards and maintain high-quality products…Jun 10Jun 10
CharlesCompliance Guide: Navigating 21 CFR Part 820 for Medical DevicesNavigating 21 CFR Part 820 in medical device manufacturing can be complex. With my years of experience as a medical regulatory consultant…Jun 7Jun 7
CharlesReddit Survey: Best QMS software in the MedDev industryChoosing the right QMS software is critical to success in the MedDev industry. To gain insight into popular options, I reached the Reddit…Jun 13, 2023Jun 13, 2023
CharlesBest QMS software for MedDev in 2022 (June)To be as successful as possible in running a company, we always strive for better tools, techniques, and technologies to achieve results…Jun 13, 2022Jun 13, 2022
CharlesHow suffocating is a paper-based system vs. eQMS?The most common case regarding poorly followed procedures is a paper-based system. From tracking, monitoring, updating, accessing…Oct 6, 2021Oct 6, 2021
CharlesMust-Have Documents and Records (ISO 9001 & ISO 13485)We all know how important documentation and records are for QMS. We need to have proof “on paper” of how, why, where,... something was…Sep 28, 2021Sep 28, 2021
CharlesDocument Management in QMS softwareWe all already know very well that QMS refers to: “if it is not documented, it did not happen”.Aug 20, 2021Aug 20, 2021
