FEATURED EDITORIAL
Statistics Abuse In QA/QC: 3 Lessons Learned
One of the best tools at our disposal in a quality assurance/quality control context (manufacturing, supplier quality, etc.) is statistics. However, you should use caution and be mindful that you use it correctly and effectively. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, shares his 3 lessons learned.
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![USA COVID 19]( "FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers")
FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For ManufacturersPublished in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.
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![iStock-917034162]( "Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk Management")
Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk ManagementYou’re familiar with ISO 14971, the “Application of Risk Management to Medical Devices” standard. Upon closer inspection, you’ll learn that this standard is in fact a standard for medical device safety risk management. However, risk management goes beyond the product safety aspects and includes strategic and operational elements. This article discusses how risk managed at one level allows for opportunities for value creation at other levels.
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![whistle]( "7 Rules For Properly Interpreting Control Charts")
7 Rules For Properly Interpreting Control ChartsIt is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements.
INDUSTRY INSIGHTS
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![cold chain iStock-878717180]( "Helium Leak Detection Technology Solves Cold Supply Chain Challenges Of Today’s High-Risk Pharmaceuticals")
Helium Leak Detection Technology Solves Cold Supply Chain Challenges Of Today’s High-Risk PharmaceuticalsVaccines and other large-molecule products require unique storage conditions, especially during the cold chain. Helium detection technology can improve the quality of drug delivery system and container design.
Designing a product with consideration for the manufacturing process can reduce production times and costs, as well as simplify development of transport, storage, and protection solutions.
A global medical device company came to Donatelle for help perfecting a silicon seal component to meet the new ISO 27186:2010 standard. In this case, a seal with micro-features is needed to reliably isolate the four-pole electrical contacts between the pacemaker and defibrillator and fit inside the 6.3 mm medical device.
The success or failure of surgical navigation is mostly influenced by a single aspect: the accurate representation of instrument positioning. Without this, the procedure and safety of the patient could be compromised. Hermetically sealed LED modules enable optical tracking technologies with reliable precision.
Devices such as introducer sheaths, delivery catheters, endoscopes, and neurovascular microcatheters aim to minimize trauma during insertion and removal, reduce tissue inflammation, enable maneuverability through tortuous blood vessels, and improve patient comfort. Surface properties should promote smooth movement between certain device components.
SOLUTIONS
The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.
Cardinal Health’s OEM division offers a large selection of latex-free hydrogels in bulk rolls or in slit widths. These medical device hydrogels are used in a variety of applications including ECG signaling, defibrillation, electrosurgical and iontophoretic return electrodes, T.E.N.S., wound care, cosmetics, and non-skin adhesives.
Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.
PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.
DSM Biomedical delivers a versatile and tunable hydrophilic polymer technology designed for adhesive applications. This technology mimics the proteins of marine mussels when they bond to underwater surfaces.
MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.
FEATURED SUPPLIERS
West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply.
MTD is a focused micro medical device manufacturer that’s built for high performance in one area: the micro molding of advanced medical products. Our experienced team will consult with you to help you refine and develop your design, using the most advanced materials and micro molding technology. We’re here to help our customers it right – from design through production – so companies can produce a high quality device, and get it to market quickly.
MED DEVICE ONLINE CONTENT COLLECTIONS
As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. Jayet Moon, author of the book Foundations of Quality Risk Management, takes a bottom-up approach to PMS with this e-book.
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