How QMS Enhances Safety and Efficiency in Blood Sugar Measurement Devices — Lessons from the FieldFostering Collaboration Between Quality and Engineering TeamsMar 26Mar 26
How QMS Enhances Safety and Efficiency in Blood Sugar Measurement Devices — Lessons from the FieldLessons from the FieldFeb 4Feb 4
How QMS Enhances Safety and Efficiency in Blood Sugar Measurement Devices — Lessons from the FieldAs a QMS manager with over 10 years of experience in the medical device industry, I’ve had the privilege of working extensively with blood…Jan 24Jan 24
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
Document 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
Prepared for Offsite Audits?Auditing today seems much simpler than before. Offsite audits were known even before the pandemic but became very popular during COVID 19.Jul 8, 2021Jul 8, 2021
The manufacturer of the medical device does not comply with ISO 13485?One of the common ambiguities of medical device startups is exactly this:Jul 5, 2021Jul 5, 2021
Similarities between ISO 13485:2016 and FDA QSRA quick reality check of ISO 13485:2016, reveals that it actually looks more, smells more, and sounds more, like FDA’s QSR. Yep! If you…Jun 28, 2021Jun 28, 2021
