FEATURED EDITORIAL

GettyImages-1282438766 Drug–Device Combination Products: Bridging Formulation, Device, And Manufacturing Decisions

Teams must assess the drug, the device, the manufacturing process, and the environment in which the product is used as an integrated system, not as separate parts. 

INDUSTRY INSIGHTS

Why Passing Audits No Longer Predicts Scale

Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations multiply, readiness depends on whether evidence stays connected.

Why Audit Success No Longer Predicts Clinical-Stage Performance

Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.

5 Hidden Risks In Manual Life Science GRC Systems

Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to scalability limits, that tend to surface only when an inspector finds them.

Navigating Recent Changes To USP <788>

A recent USP <788> revision introduces meaningful changes to particulate matter testing methods, with implications for laboratories working with small-volume injectable products.

SOLUTIONS

Components with a copper barrier and a tin finish on top provide a fully non-magnetic component to be used in medical applications where non-magnetic components are required.

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.

Battelle brings together deep experience in bioinformatics, biologics, chemistry and related fields to deliver innovative in vitro technologies with unparalleled accuracy and detection limits — all at unprecedented speed and with significant cost savings.

Quick Time To Market, Significantly Lower Risk

Daikyo Crystal Zenith® Luer Lock syringes are designed to fit a variety of standard drug delivery devices, and compared to glass they offer unprecedented strength, durability, and protection.

The High Resolution 2048R SWIR camera with capture rates of 10,000 to 147,000 lines per second for Spectral-Domain Optical Coherence Tomography.

To help you bring your medical products to market accurately and on schedule, Donatelle provides 24/7 assembly and packaging as part of their suite of integrated services. They have an impeccable track record of meeting project deadlines and maintain a 99%+ on-time delivery rate.

FEATURED SUPPLIERS

Accumold® is a high-tech manufacturer of precision micro, small and lead frame injection molded plastic components

The Lee Company is a leading supplier of miniature, precision fluid control products to a wide range of industries including medical devices and scientific equipment.

MED DEVICE ONLINE CONTENT COLLECTIONS

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Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.

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