Newsletter | January 18, 2024

01.18.24 -- Key Regulatory-Fueled Updates On Combination Products As We Enter 2024


Key Regulatory-Fueled Updates On Combination Products As We Enter 2024

In late November, AFDO/RAPS held their annual Combination Products Summit in Fort Worth, TX. The meeting is co-sponsored by the FDA with heavy involvement from the Office of Combination Products, and its representatives covered several themes on the subject as we prepare to enter 2024.


Embrace A Contract Manufacturer Partnership That Drives Sustainability

Medtech OEMs, contract manufacturers, and other partners involved in the device life cycle are increasingly realizing additional benefits by making sustainability a group exercise.

Overcoming Melt Processing Challenges For Drug Delivery Systems

Discover how a biodegradable polymer platform that can be easily applied with hot melt processing enables processing at a relatively low temperature, preserving the potency of temperature-sensitive APIs.

Non-Magnetic Trimmer Capacitors For In-Suite Or Portable MRI Machines

Explore the types of non-magnetic surface-mount device (SMD) capacitors, including trimmer capacitors, that are crucial for maintaining reliability and optimal performance in POC MRI machines.

A Guide To Vaporized Hydrogen Peroxide Isolator Decontamination

This field guide uses current published resources to provide clarity and direction regarding best practices for validating decontamination processes using VH2O2.

Extruded Medical Tubing: Process Parameters, Equipment Play Critical Role

Most medical tubing specifications comprise a drawing of a tube with the material, dimensions, and tolerances. However, parameters associated with the production of the tubing are also key.

3 Key Trends For The Future Of Medical Device Automation

Donatelle's Raghu Vadlamudi introduces trends medical device manufacturers need to be prepared to adopt in order to create next-generation medical devices and components.


Key Considerations In "Intended Use" And "Indications For Use" Statements For Medical Devices

The Secret To Medical Device Development Success: A Mindset For Continuous Learning

Can Aptamers In Wearable Sensors Mean A Revolution In Healthcare?

How To Make The FDA Happy: 7 Medtech Design Pro Tips For Combination Products

Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices


A Single-Source Partner For 5-Component Device

Brochure: Insert vs. Overmolding

Injection Molding

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