Newsletter | March 26, 2024

03.26.24 -- Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity

FEATURED EDITORIAL

Getting Out Of The Doldrums: Kickstarting Organizational Quality Maturity

By Samantha Atkinson, NSF

It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.

INDUSTRY INSIGHTS

Choosing A Partner For Micromolded Silicone Implantable Parts

Article | By Dennis Rector, Flexan

Micromolding is used for products that require tolerances within the micron range, including components in minimally invasive surgical tools, valves, and seals.

How To Select An RFID Partner To Enhance Your Medical Devices

White Paper | HID

Discover RFID's advantages in medical devices, guidance for supplier selection, and success stories from healthcare's RFID integration, offering valuable insights and practical examples.

Increasing Delivery System Flexibility Through Solvent-Based Processing

Article | By Matilde Putti, Ph.D., DSM Biomedical

Learn how a biodegradable polymer platform that is compatible with many substrates can enable several applications as a drug-eluting carrier with a wide variety of APIs.

Streamlining Catheter-Based Devices With Advanced Multilayer Tubing

Application Note | Nordson MEDICAL

Discover how breakthroughs in multilayer tubing extrusion technology enable next-generation catheter-based medical devices.

Is It Ever Too Soon To Start Your Performance Testing Assessment?

Article | By Mike Ulman, West Pharmaceutical Services, Inc.

Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of critical quality attributes (CQAs), and performing design verification testing.

High-Volume Manufacture Of Thin-Wall Medical Device Components With LCP

White Paper | Celanese

The advantages of liquid crystal polymer (LCP) thermoplastics are translatable to precision combination drug delivery devices, which incorporate complex mechanisms and wireless connected electronics.

ARTICLES YOU MAY HAVE MISSED

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Using Relational Risk Analysis To Control Procedure Failures

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A Successful Technology Strategy For Medical Device Teams Asking, “Own Or Partner?”

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6 Things Medtech Companies Should Know About The EU’s AI Act

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New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis

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A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis

RESOURCES

Characterization & Delivery Of Ultra-Viscous & Non-Newtonian Formulations

SMC Ltd.

Optical Molding Capabilities Across Markets

Accumold

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