AI in Life Science QMS: Transforming Quality Management
In the past two years, AI has vaulted from pilot projects to board-level priority in life-science quality. The U.S. FDA now lists more than 1,000 AI-enabled medical devices cleared for market use—a milestone that signals regulators are comfortable ap...
21 CFR Part 210 cGMP: Everything You Need to Know
Manufacturing pharmaceutical products requires attention to detail and an unwavering commitment to quality. The stakes are incredibly high, directly impacting public health and safety. The United States Food and Drug Administration (FDA) established ...
Integrated Quality Management System: Key Benefits
Do you struggle with disconnected processes, mountains of paperwork, and a constant battle to maintain quality across your organization? Many businesses face these exact challenges. An integrated quality management system (IQMS) provides a solution t...
Job Hazard Analysis (JHA): What It Is & How to Implement It?
Have you ever wondered what separates a great work culture from a mediocre one? It’s the focus on employees and prioritization of their physical and mental well-being. Today, in the post-pandemic world, job hazard analysis is no longer an option; it ...
In Vitro Diagnostic (IVD) Devices: Compliance Guide
Most people still picture an IVD as the little blue-and-pink pregnancy test in their bathroom drawer. Cute—but today’s in-vitro diagnostics range from AI-driven next-generation sequencing panels to COVID swabs you run at the kitchen table. In short, ...
Key Components and Elements of GMP
Good Manufacturing Practices (GMP) define the framework through which quality, safety, and consistency are built into every stage of the manufacturing lifecycle - it's a non-negotiable requirement.
Top Qualityze KPIS in Manufacturing Industry You Must Know
In today’s precision-driven manufacturing world, not tracking a quality KPI in manufacturing industry is like flying blind. To achieve operational excellence in a very competitive environment, there is one quality KPI in the manufacturing industry th...
How to Write Non-Conformance Report the Right Way
For quality and compliance leaders, audit readiness starts long before the regulator walks in. A non-conformance report (NCR) helps businesses capture, analyze, and resolve deviations from established processes, product standards, or regulatory requi...
510K VS PMA Notifications & Approvals - What You Need to Know
The FDA’s 510k and PMA pathways are not interchangeable in forms—they represent two fundamentally different approval mechanisms designed for devices with varying clinical risks and market maturity. Whether you’re building a Class II monitor or a nove...
Tree Diagram in Quality Management : Definition & Steps
Organizations in today's quality-focused world require more than intuitive gut-feeling problem solving; they require systematic, data-based tools. One such critical methodology is the tree diagram in quality management. This effective visualization m...
Importance of Quality Control and Assurance in Manufacturing
In manufacturing, a single quality lapse can spiral into a compliance crisis. That’s why quality control and assurance in manufacturing must be engineered into the process, not just inspected at the end.
The difference between a scalable busines...
How eCRF in Clinical Trials Improves Compliance
eCRF in clinical trials has revolutionized how data is collected, validated, and submitted. This guide explains its features, benefits, and role in regulatory compliance. Learn the difference from paper CRFs, explore best practices, and see how Quali...
Cloud Document Management System with AI
In today’s fast-moving digital world, businesses are flooded with documents—policies, procedures, records, and more. Managing all of that manually or with outdated systems? That’s a recipe for chaos.
FDA Class 2 Medical Device: Everything You Need to Know
If you imagine the FDA’s medical-device rulebook as a three-lane highway, Class II sits in the middle lane—devices that carry more risk than a tongue depressor but far less than a heart valve. By FDA count, there are over 1,700 individual device type...
FDA Class 1 Medical Device
Picture the last time you reached for a simple adhesive bandage or a manual stethoscope. Although these tools feel ordinary, the U.S. Food and Drug Administration (FDA) still regulates them—just under the lightest level of oversight, known as Class I...
CAPA For Medical Devices Industry
From patient safety to global compliance, CAPA for medical devices industry supports every aspect of quality management. This expert guide covers CAPA system requirements, RCA methods, and the right software for your QMS. Discover how to implement CA...
Medical Device Classification
Ever wonder why a tongue depressor can hit the market on a shoestring while a transcatheter heart valve wades through years of data and seven-figure fees? It all boils down to three letters: I, II, III—the FDA’s risk-based ladder that sorts more than...
Best Medical Device Quality Management System (QMS) Software
People don’t buy a medical device—they buy the promise that it was built, tested, and shipped the right way.
Sure, people cite different reasons for picking a brand—FDA clearance, safety for kids, ease of use, a doctor’s nod. But it all collapse...
Different Types of Quality Management Syste
If “just get a QMS” ever felt like useless advice, this is your clarity shot: what each type does, where it shines, and how to choose without guesswork.
Ever felt like your quality processes are stitched together with duct tape and good intention...
Medical Device Startup Companies to Watch in 2025
Over the last decade, medical device innovation has moved from incremental upgrades to breakthrough, patient‑centric inventions. Startups now sit at the forefront, turning bold concepts into devices that hospitals and home users quickly adopt.
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FDA 21 CFR Part 11: A Complete Guide You Need
Remember that low‑simmer anxiety you feel when someone in Quality murmurs, “The FDA is in the lobby”? You’re not alone—and the numbers back it up. In fiscal 2023, investigators knocked on 18,539 doors, and nearly one‑third of those visits ended with ...
Good Distribution Practices (GDP) in Pharma Industry
Good Documentation Practices (GDP) are a cornerstone of quality management systems in regulated industries, particularly in pharmaceuticals, medical devices, and clinical research. The FDA defines GDP as the disciplined process of preparing, reviewin...
Types of Quality Control in Pharmaceutical Industry
Quality professionals know the feeling: one overlooked specification, and suddenly the FDA dashboard becomes the focal point of the night. It might be difficult to believe for those who haven’t really faced it. But it is good to be aware of things th...
Manufacturing Inspection & Quality Control
Every finished part that rolls off a line carries your company name—and the weight of global regulations behind it. Whether you build micro-valves for pacemakers or chassis parts for EVs, authorities such as ISO (ISO 9001:2015), the U.S. FDA (21 CFR ...
How eCRF in Clinical Trials Improves Compliance
eCRF in clinical trials has revolutionized how data is collected, validated, and submitted. This guide explains its features, benefits, and role in regulatory compliance. Learn the difference from paper CRFs, explore best practices, and see how Quali...
Cloud Document Management System with AI
In today’s fast-moving digital world, businesses are flooded with documents—policies, procedures, records, and more. Managing all of that manually or with outdated systems? That’s a recipe for chaos. The good news? There’s a better way: A cloud-base...
CAPA for Medical Devices: Ensure Compliance and Quality
Quality issues in medical devices are rarely isolated from events- rather they are often signals of deeper system vulnerabilities. That is the primary reason that CAPA for medical devices industry has transformed from a reactive process to a strategi...
ISO 14971: Risk Management Guide for Medical Devices
Medical devices significantly impact patient care, directly influencing health outcomes and quality of life. However, these devices inherently carry risks, which can result in harm if not effectively managed. To address this critical issue, ISO 14971...
ISO 9001 Quality Management Principles You Must Know
Coffee machines that never leak, airplanes that land on time, and cloud apps that stay online – all three share a common backbone: a documented, continuously improving quality management system (QMS). ISO 9001 is the global rulebook for that backbone...
ISO 9001 Clause 8.5.2 Identification & Traceability
Organizations across quality-focused business environments face increasing pressure to deliver consistently reliable and safe products. Meeting customer expectations and regulatory requirements is no longer optional—it’s critical to maintaining reput...
