Newsletter | December 21, 2023

12.21.23 -- Understanding The FDA's New Medical Device Cybersecurity Guidelines


Understanding The FDA's New Medical Device Cybersecurity Guidelines

The FDA cybersecurity requirements for medical “cyber devices” went into effect on October 1, 2023. The FDA has made it clear that it cannot accept submissions that don’t meet these requirements. Here are four steps to navigate the new requirements.

Liquid Biopsy: The Next Evolution In Personalized Prostate Cancer Screening

The prostate-specific antigen (PSA) blood test has long been the gold standard in prostate cancer diagnostics. More recently, liquid biopsy, which includes the analysis of circulating tumor material in the blood or urine, has emerged as a promising non-invasive tool.


What Is An Aqueous Cleaner?

This chapter of The Aqueous Cleaning Handbook explains what an aqueous cleaner is, what it contains, and how it can improve your cleaning process.

Change Control: Considerations For Medical Device Components

Explore the various factors that must be considered when faced with such modifications, and what processes must be implemented in advance as part of a robust quality management system.

Taking A Flexible Approach To Autoinjector Assembly Equipment

Examine how a flexible, scalable, and efficient solution for the assembly of autoinjectors can help you stay ahead of the competition and meet the demands of an ever-changing industry.

Inspection Of Injectable Products For Visible Particulates

Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables.

Performance Of Bioprosthetic Heart Valves: Material Considerations

Explore modern developments in heart valve prostheses that have followed closely with advancements in available biomaterials.

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.

RFID For Med Devices: Identifying A Partner

RFID is increasingly being used in medical devices. Utilize this guidance on finding a suitable RFID partner, including what to look for in a supplier, case studies, and proprietary technologies.

Simplify Complex Parts Sourcing With Artificial Intelligence

Here, we reveal how a business platform powered by artificial intelligence simplified complex parts sourcing and standardization while keeping costs low in medical device design and delivery.


Growth Strategies Pushing The Next Wave Of Surgical Robotics

Measurement System Analysis Using Continuous Gage R&R Studies, Part 1

Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2

Emerging Market Trends For Drug Delivery Devices

ML-Powered Medical Devices: 10 Tips For Regulatory Compliance


Micro 3D Printing Handbook

Additive manufacturing (AM) and micro 3D printing have disrupted the way microsized parts are designed and manufactured. Advances enable faster prototyping, faster production, more complex geometry, and smaller sizes.

Advanced Tubing Retainers: Pharma+

Designed to secure tubing over hose barbs effortlessly, Pharma+ retainers feature a revolutionary lead-in ramp ensuring complete 360° compression to prevent leaks.


Understanding Complexities Of Bioabsorbable Materials Achieves Consistent IV Loss

High-Viscosity Formulations: Developing A ‘Human Solution’ To Autoinjector Design

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