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Stay ahead of the curve with information on the latest medical manufacturing markets where innovative technologies and processes are used to produce life-saving and life-changing medical devices that meet the highest standards of quality and safety.

]]> https://www.qualitymag.com/rss/2675-medical en-us Tooling Quality Drives Injection Molding Performance Quality control programs in injection molding are often focused on monitoring production – measuring dimensions, tracking variation, and verifying consistency across runs. 

]]> http://www.qualitymag.com/articles/99606 Wed, 27 May 2026 15:00:00 -0400 https://www.qualitymag.com/articles/99606-tooling-quality-drives-injection-molding-performance an employee working with injection molding tooling in a manufacturing setting an inside view of the Hoffer Plastics Corporation custom injection molding manufacturing facility a worker arranging tools on a workbench alongside a blue exchange icon From QSR to QMSR: What Medical Device Manufacturers Need to Change—and What They Don’t The FDA’s new Quality Management System Regulation (QMSR) represents the most significant shift in FDA quality system compliance in over 25 years.

]]> http://www.qualitymag.com/articles/99549 Tue, 28 Apr 2026 00:00:00 -0400 https://www.qualitymag.com/articles/99549-from-qsr-to-qmsr-what-medical-device-manufacturers-need-to-changeand-what-they-dont If Safety Is on the Line: Designing a Quality Strategy That Does Not Overtrust Tools Quality teams now rely on a dense stack of tools: automated test frameworks, AI assisted test generation, self healing locators, visual testing, static analysis, and observability platforms. 

]]> http://www.qualitymag.com/articles/99485 Mon, 23 Mar 2026 00:00:00 -0400 https://www.qualitymag.com/articles/99485-if-safety-is-on-the-line-designing-a-quality-strategy-that-does-not-overtrust-tools VIDEO PODCAST | What A Quality Signature Really Means Priyank Patel is a quality expert in the med-tech space, focusing on surgical robots. He's a senior member of ASQ with ASQ certification.



]]> http://www.qualitymag.com/articles/99445 Mon, 02 Mar 2026 00:00:00 -0500 https://www.qualitymag.com/articles/99445-video-podcast-what-a-quality-signature-really-means When Milestones Lie: Why Medical Device Teams Fall Out of Alignment and How to Prevent It From a regulatory standpoint, progress in medical device development is measured by evidence, not by phase completion.

]]> http://www.qualitymag.com/articles/99430 Tue, 24 Feb 2026 00:00:00 -0500 https://www.qualitymag.com/articles/99430-when-milestones-lie-why-medical-device-teams-fall-out-of-alignment-and-how-to-prevent-it Medical Device Manufacturers Redefine Quality Amid Digital, Regulatory and Supply Chain Pressures Medical device manufacturers are changing how they inspect devices, manage suppliers, and evaluate performance over a product’s lifecycle.

]]> http://www.qualitymag.com/articles/99385 Sat, 07 Feb 2026 00:00:00 -0500 https://www.qualitymag.com/articles/99385-medical-device-manufacturers-redefine-quality-amid-digital-regulatory-and-supply-chain-pressures Precision in Every Micron: Optical Surface Metrology in Medical Device Manufacturing In medical device manufacturing, the difference between life-saving success and catastrophic failure is often measured in nanometers. 

]]> http://www.qualitymag.com/articles/99375 Mon, 02 Feb 2026 00:00:00 -0500 https://www.qualitymag.com/articles/99375-precision-in-every-micron-optical-surface-metrology-in-medical-device-manufacturing The image shows a Mahr MarSurf3D MS coordinate measuring machine (CMM). The image displays a 3D surface map of a dental implant's surface roughness, likely generated using a measurement technique like interferometry or confocal microscopy. This image displays a 3D topography map of a surface, likely used for analyzing its roughness. The image displays a surface topography map, likely generated using optical metrology or similar technology. The image illustrates a surface texture analysis, specifically measuring the roughness parameter "Ra" on a metallic orthopedic implant. The image displays a 3D visualization of surface texture, likely captured using an optical profiler or laser confocal microscope Medical Device Regulation in the U.S. In February 2024, the FDA took a bold step that will change the regulatory landscape of the medical devices industry as we know it.

]]> http://www.qualitymag.com/articles/99348 Mon, 19 Jan 2026 00:00:00 -0500 https://www.qualitymag.com/articles/99348-medical-device-regulation-in-the-us Bridging Compliance and Innovation: Quality Assurance in the Era of Intelligent Medical Devices sairanjith.ramakrishnan@gmail.com (Sai Ranjith Ramakrishnan Kumar) When people think of medical devices, they often picture pacemakers, insulin pumps, or MRI scanners. Increasingly, however, medical innovation no longer comes in metal or plastic—it comes in code. Software as a Medical Device (SaMD) refers to software intended to perform a medical function without being part of a physical device.

]]> http://www.qualitymag.com/articles/99261 Tue, 02 Dec 2025 00:00:00 -0500 https://www.qualitymag.com/articles/99261-bridging-compliance-and-innovation-quality-assurance-in-the-era-of-intelligent-medical-devices Validating the Process: Why Test and Validation are Critical to Quality in MedTech Molding In medical device manufacturing, precision is not optional. Every molded component must meet exacting requirements for safety, reliability, and compliance.

]]> http://www.qualitymag.com/articles/99252 Sat, 29 Nov 2025 00:00:00 -0500 https://www.qualitymag.com/articles/99252-validating-the-process-why-test-and-validation-are-critical-to-quality-in-medtech-molding From Paper to Performance: The Strategic Transition to Electronic Device History Records (eDHRs) The stakes for quality in medical device manufacturing have never been higher. Products are becoming more complex, regulatory expectations continue to evolve, and the pressure to deliver faster, more efficiently, and with total traceability is growing every day.

]]> http://www.qualitymag.com/articles/99215 Mon, 10 Nov 2025 00:00:00 -0500 https://www.qualitymag.com/articles/99215-from-paper-to-performance-the-strategic-transition-to-electronic-device-history-records-edhrs VIDEO PODCAST | The Evolving Role of Quality in the AI-Enabled Medical Device Industry Listen to the latest podcast with Sai Ranjith, a quality engineer with over eight years of experience in the medical device industry. He focuses on regulatory compliance and risk management. He has a Six Sigma green belt and is an ISO 13485:2016 Medical Device Auditor. He also serves as program chair for the Granite State Chapter of ASQ.

]]> http://www.qualitymag.com/articles/99194 Fri, 31 Oct 2025 00:00:00 -0400 https://www.qualitymag.com/articles/99194-video-podcast-the-evolving-role-of-quality-in-the-ai-enabled-medical-device-industry Quality at an Inflection Point: Why MedTech Needs Predictive, Not Just Compliant, Systems Artificial intelligence is revolutionizing patient safety and tackling labor shortages in medical manufacturing. As quality engineers adapt, the emphasis on quality assurance and specialized inspections intensifies. This editorial explores how AI is transforming processes and building trust in the medical device industry.

]]> http://www.qualitymag.com/articles/99165 Wed, 15 Oct 2025 00:00:00 -0400 https://www.qualitymag.com/articles/99165-quality-at-an-inflection-point-why-medtech-needs-predictive-not-just-compliant-systems Medical Device Q&A bangertm@bnpmedia.com (Michelle Bangert) Sai Ranjith Ramakrishnan Kumar (Sai) is a medical device quality engineering expert, Six Sigma Green Belt Certified, and programs chair of ASQ Granite State Section. Quality talked with him about his contributions to advancing quality practices in industry and beyond, focusing on enhancing patient safety, ensuring regulatory compliance, and driving innovation in the profession.

]]> http://www.qualitymag.com/articles/99116 Fri, 03 Oct 2025 00:00:00 -0400 https://www.qualitymag.com/articles/99116-medical-device-q-and-a Quality and Visibility as a Service in Medical Contract Manufacturing Integrated solutions combining ERP, MES, and QMS functionalities are replacing standalone QMS software in quality assurance. This shift enables real-time data collection and improved quality control. Medical device contract manufacturers can use these systems to enhance their quality services and gain a competitive advantage beyond cost and scrap reduction.

]]> http://www.qualitymag.com/articles/99105 Mon, 29 Sep 2025 00:00:00 -0400 https://www.qualitymag.com/articles/99105-quality-and-visibility-as-a-service-in-medical-contract-manufacturing AI Transforms Patient Safety and Tackles Labor Shortages in Medical Manufacturing jay.elepano@zeiss.com (Jay Elepano) Precision is crucial in medical manufacturing, yet the industry faces labor shortages and increasing complexity. AI developments offer a solution by enhancing human expertise, enabling manufacturers to operate efficiently with limited labor and time while also improving patient safety and production resilience.

]]> http://www.qualitymag.com/articles/98995 Tue, 12 Aug 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98995-ai-transforms-patient-safety-and-tackles-labor-shortages-in-medical-manufacturing The Evolving Role of the Quality Engineer in an AI-Enabled Medical Device Industry sairanjith.ramakrishnan@gmail.com (Sai Ranjith Ramakrishnan Kumar) The medical device industry is evolving with AI and automation affecting production and quality management. Quality engineers are moving towards systems thinking and proactive decision-making, as AI becomes integral to production, presenting challenges and opportunities for innovation while ensuring safety.


]]> http://www.qualitymag.com/articles/98958 Thu, 31 Jul 2025 01:37:46 -0400 https://www.qualitymag.com/articles/98958-the-evolving-role-of-the-quality-engineer-in-an-ai-enabled-medical-device-industry Product Definition and Regulations This article explains how a Quality leader can establish external requirements by defining products in a specific region, using medical devices as an example based on FDA regulation Section 201(h) and the 513g Request process. Following this prevents wasting time, funds, and resources on incorrect regulatory assumptions.

]]> http://www.qualitymag.com/articles/98917 Tue, 15 Jul 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98917-product-definition-and-regulations Building Trust: The Role of QA/QC and Specialized Inspections in High-Stakes Manufacturing Industries like aerospace and automotive now require stringent quality assurance, focusing on proactive measures throughout the product lifecycle to ensure safety and continuous improvement.


]]> http://www.qualitymag.com/articles/98822 Wed, 11 Jun 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98822-building-trust-the-role-of-qa-qc-and-specialized-inspections-in-high-stakes-manufacturing Artificial Intelligence Meets Medical Quality Atty Chakraborty, our 2025 Quality Rookie of the Year, discusses her work in the emerging field of AI in the medical industry, including examples, predictions for the future, and how it may apply in your work.

]]> http://www.qualitymag.com/articles/98756 Wed, 21 May 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98756-artificial-intelligence-meets-medical-quality Why it Pays to Prioritize Quality Amid Regulatory Uncertainty In 2025, medical device manufacturers are grappling with heightened regulatory uncertainty, leading to slower reviews and communication difficulties with the FDA. This situation drives them to reassess operations for compliance and risk management, with a strong emphasis on maintaining product quality, which is vital for patient safety.

]]> http://www.qualitymag.com/articles/98743 Wed, 14 May 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98743-why-it-pays-to-prioritize-quality-amid-regulatory-uncertainty PODCAST | She Came, She Saw, She Started a Career Meet our 2025 Quality Rookie of the Year, Attrayee Chakraborty. She is a quality professional in the medical field with a background in biotechnology and expertise in Artificial Intelligence (AI).

]]> http://www.qualitymag.com/articles/98698 Thu, 01 May 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98698-podcast-she-came-she-saw-she-started-a-career Meet the 2025 Rookie of the Year: Attrayee Chakraborty bangertm@bnpmedia.com (Michelle Bangert) Quality is honored to name Attrayee Chakraborty as our 2025 Quality Rookie of the Year. Discover how she earned the award through her groundbreaking work in medical device quality and AI integration.

]]> http://www.qualitymag.com/articles/98680 Tue, 29 Apr 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98680-meet-the-2025-rookie-of-the-year-attrayee-chakraborty Safe and Sane: Understanding the FDA’s Risk-Based Approach to AI The life sciences sector is at a crossroads as the FDA updates quality management standards. AI is now expected, and the FDA's January 2025 draft guidance outlines its evaluation and implementation. Successful adoption depends on three key questions.

]]> http://www.qualitymag.com/articles/98697 Mon, 28 Apr 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98697-safe-and-sane-understanding-the-fdas-risk-based-approach-to-ai PODCAST | Train and Maintain With the Right Software Quality interviewed the CEO of Spectrum Custom Packaging, our 2025 Plant of the Year, on how to train, maintain high quality, and find the right software.

]]> http://www.qualitymag.com/articles/98690 Thu, 24 Apr 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98690-podcast-train-and-maintain-with-the-right-software How RGB-IR Cameras Are Transforming Medical Imaging RGB-IR camera technology simultaneously captures standard color (RGB) and infrared (IR) light using a specialized filter. This integration enhances medical imaging by providing improved diagnostic capabilities through dual-spectrum capture.

]]> http://www.qualitymag.com/articles/98653 Tue, 01 Apr 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98653-how-rgb-ir-cameras-are-transforming-medical-imaging Quality Management and Regulatory Compliance in Pharmaceutical Manufacturing Kalpita Mehta is a combination products and medical device expert at a top U.S. generic manufacturer. She specializes in developing complex pharmaceutical products like COVID-19 testing kits.

]]> http://www.qualitymag.com/articles/98648 Sat, 29 Mar 2025 00:00:00 -0400 https://www.qualitymag.com/articles/98648-quality-management-and-regulatory-compliance-in-pharmaceutical-manufacturing 2025 Quality Plant of the Year: Spectrum Custom Packaging bangertm@bnpmedia.com (Michelle Bangert) Keeping defects low and reducing scrap is not an easy task. But Spectrum Custom Packaging made it happen. Meet Quality's 2025 Plant of the Year.

]]> http://www.qualitymag.com/articles/98590 Fri, 28 Feb 2025 03:00:00 -0500 https://www.qualitymag.com/articles/98590-2025-quality-plant-of-the-year-spectrum-custom-packaging Reducing Test Result Scatter: A Crucial Step in Medical Device Testing James.Ritchey@ZwickRoell.com (James Ritchey) The medical device industry needs strict testing that meets evolving standards. Collaboration between manufacturers and standards committees ensures accurate and reliable testing solutions. Automation can standardize processes, tackle the shortage of qualified lab personnel, and enhance quality and efficiency.

]]> http://www.qualitymag.com/articles/98586 Tue, 25 Feb 2025 00:00:00 -0500 https://www.qualitymag.com/articles/98586-reducing-test-result-scatter-a-crucial-step-in-medical-device-testing Unlocking the Potential of APIs in Medical Device Innovation Medical device companies are adopting APIs to enhance operational efficiency and speed up product development while meeting regulatory requirements. APIs enable seamless data exchange between software systems, streamlining processes like clinical trial data collection and quality management.

]]> http://www.qualitymag.com/articles/98483 Tue, 31 Dec 2024 00:00:00 -0500 https://www.qualitymag.com/articles/98483-unlocking-the-potential-of-apis-in-medical-device-innovation