Newsletter | October 17, 2023

10.17.23 -- Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development

FEATURED EDITORIAL

Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development

The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.

INDUSTRY INSIGHTS

Gamma, Ebeam, Or X-Ray? The Future Of Radiation Sterilization

Explore gamma, Ebeam, and X-ray sterilization modalities, along with comparative studies by leading academic and trade organizations, including the conclusions they draw on sterilization techniques.

Four OEM Benefits For RFID-Enabled Medical Devices

RFID technology has changed the ways in which OEMs fabricate, distribute, and market modern medical devices and provides medical facilities and their patients with real and measurable benefits.

Parameters Affecting Vapor Hydrogen Peroxide Biological Indicator Performance

We review the potential benefits and difficulties of using vapor hydrogen peroxide (VHP) in decontamination and sterilization.

Hostraform POM ECO-B: Proven Versatile, Easy, And Environmentally Sustainable

There is a need for environmentally sustainable materials in the medical device industry, and Celanese’s Hostaform MT POM ECO-B fills the gap. From feasibility to development to commercialization, Celanese’s scientists and engineers are there to provide development services, GMP material supply, and regulatory support.

Introducing The MD Series Of Medical-Grade Capacitors For Implantable Device Design

The MD series of medical-grade capacitors is designed to meet MIL-SPEC standards, addressing the reliability needs of medical implantable devices.

Digital Transformation In Production Planning And Scheduling

Planning systems for manufacturers are valuable communication and coordination vehicles for breaking down interdepartmental barriers. Learn about improving your planning systems, "smart" manufacturing, production, enterprise resource planning, and more.

Top 5 Applications For Ultrathin-Wall Heat-Shrink Tubing In Medical Device Design And Manufacturing

This application note provides medical device engineers ideas for applications that are ideally suited for ultra-thin-walled PET heat-shrink tubing. Applications explored in this paper include variable-stiffness catheters, protective covering/coating and bundling, reinforcement, tube making and printing, and electrical insulation.

Getting Fast-Tracked Complex Class III Orthopedic Device To Market On Time — And In Spec

Donatelle helped a biotech company successfully produce a Class III orthopedic device on time and in spec with the support of their engineering team, facilities, and quality management systems.

ARTICLES YOU MAY HAVE MISSED

A Brief Guide To ISO 13485’s Design Controls In Medical Device Development

Biosensing Technology: Where Is The Field Headed?

Global Market Trends For Drug-Device Combination Products

FDA’s Grace Period For Medical Device Cybersecurity Is Over. Are You Ready?

The Landscape For Conducting Medtech Clinical Trials In The Dominican Republic

RESOURCES

Uni-Patch C Series (First Choice) Stimulating Electrodes

A Step Change In Pharmaceutical Glass Packaging Innovation

Adhesive Films Coatings And Sealants Technology

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