Newsletter | December 12, 2023

12.12.23 -- Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies

FEATURED EDITORIAL

Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1

All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a three-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.

INDUSTRY INSIGHTS

How To Reduce The Complexity Of Single-Use Systems

Explore five key benefits of genderless aseptic connectors and how they can lead to more flexibility, reduced risk, and lower costs for your organization.

Why Perform A Product D-Value Study?

Follow our discussion on non-heat-sensitive aqueous liquid product sterilization and the use of the overkill method and the bioburden/BI method.

Prioritize Process Validation To Mitigate Manufacturing Risks

Medical device manufacturers must prioritize process validation to ensure safe and effective performance. Neglecting this can lead to severe consequences. This article covers essential elements of process validation due diligence.

Three Considerations When Introducing A New Medical Device

When a company brings a new medical device to market, the road can be long and complex. There are several regulatory concerns to navigate. Additionally, there are some very important considerations regarding manufacturing. Manufacturing processes, assembly requirements, packaging, and other factors must come into play right from the start.

Current Trends In Medical Kit Packaging

Today’s version of the medical procedure kit comprises stackable, efficient, sterile, and identifiable trays or pouches stocked with essential equipment for specific surgeries, tests, and examinations. 

5 Ways Manufacturers Optimize Consumables Programs With RFID

RFID technology helps manufacturers, who rely on repeat sales of consumable components, combat threats to profitability and performance, while ensuring superior operability for their end-use customers.

Material Behavior At The Micro Scale: The Core Of Medical Device Innovation

Material behavior on the micro level is very different than what traditional (macro-level) plastics engineering has taught us. In this white paper, learn about polymer mechanics and how it might impact material selection for your micro medical device.

ARTICLES YOU MAY HAVE MISSED

Emerging Market Trends For Drug Delivery Devices

ML-Powered Medical Devices: 10 Tips For Regulatory Compliance

SaMD PCCP Implementation Beyond AI/ML: Considerations And Challenges

A Risk-Based Approach To Assess Particulate Generation For Cardiovascular Devices

The Positive Impact Of The Voluntary U.S. Cyber Trust Mark On IoMT Devices

BULLETIN BOARD

Facility Video Tour: Orchard Park, New York

Take a look inside our ISO 13485 certified Orchard Park, NY, locations featuring two full-service facilities: one dedicated to silicone and the other for thermoplastics injection molding.

RESOURCES

Guide To Medical Devices Quality Control And Testing

Packaging And Containment: Get Your Products To Market Faster

Capacitors For Medical Implantable Devices

Biodegradable Polyester Amide Platform

Ateva G EVA The Optimized Solution For Phosphite-Free, Bio-Compatible SUS

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