Mastering Audit Readiness: Essential Strategies and Tools for QMS Professionals in the Medical…Why Audit Readiness Is the Cornerstone of Success in the Medical Device IndustryNov 18, 2024Nov 18, 2024
Navigating 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…Nov 6, 2024Nov 6, 2024
Is 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 29, 2024Oct 29, 2024
NHS 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 24, 2024Jun 24, 2024
Validating 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 10, 2024Jun 10, 2024
Compliance 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 7, 2024Jun 7, 2024
Reddit 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
Best 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
How 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
Must-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
