Newsletter | December 5, 2023

12.05.23 -- ML-Powered Medical Devices: 10 Tips For Regulatory Compliance

FEATURED EDITORIAL

ML-Powered Medical Devices: 10 Tips For Regulatory Compliance

This article summarizes the 10 principles in the FDA’s Good Machine Learning Practice for Medical Device Development: Guiding Principles, each of which is critical in developing medical devices powered by machine learning (ML). The author also provides tips for how you can employ them.

INDUSTRY INSIGHTS

Overcoming Challenges With Metal Cerclage Cables

Although metal cerclage cables work well in many instances, recently, polymer cerclage cables have begun to take market share due to an accumulation of smaller benefits relative to traditional metallic cables.

An Overview Of Silicone Micro Molding

Explore the world of silicone micro molding — where engineers navigate complex challenges in handling unique properties, such as addressing static cling and inspection difficulties.

Measuring Cleanliness

Learn about methods of detecting and measuring cleanliness in relation to soil quantities.

How Smart Factories Are Changing The Future Of Medical Device Manufacturing

New automation technologies in manufacturing have made it possible to minimize errors, leading to improved patient safety, cost savings, and faster turnaround. Micro-manufacturing and 3D printing are also contributing to game-changing innovations.

Applying Quality Systems Approach To Improve Supply Chain Management

This article presents a quality systems technique that is ideal for improving trust between a manufacturer and a supplier, as well as improving the overall quality of medical devices.

The 6 Sciences Of Medical Micromolding: How To Achieve Better Long-Term Results And Faster Speed-To-Market

The smallest parts often carry with them the greatest importance relative to the functionality and safety of a medical device. MTD refers to its micromolding tools as the company’s “six sciences" and its road map to success. 

Tech Talk: Control Valves For Metabolic Monitoring

The Lee Company’s extensive offering of miniature two-way and three-way control valves are ideal for metabolic monitor designers looking for solenoid valves to feed sensors, mix gases, and vent to atmosphere. Several standard options for drive voltage, seal material, and mounting are available to facilitate easy integration into new and existing platforms.

Nonmagnetic Trimmer Capacitors For In-Suite Or Portable MRI Machines

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

ARTICLES YOU MAY HAVE MISSED

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

Deciphering New U.S. Laws Around Predetermined Change Control Plans

FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products

BULLETIN BOARD

Medical Device Manufacturing And RFID

This webinar explains how integrating RFID technology in medical device design enhances value throughout the supply and use chain by authenticating and locating devices of all sizes.

RESOURCES

Sterilization Cycle Development

The Advantages Of Shotscope

Stopcocks And Manifolds

Flexan Offers Rapid Extrusion

EVENTS

CMCU Digital Radiography (DR) Group Introduces Clinical White Paper On Intelligent Noise Reduction In Pediatric Radiography Study

Canon Medical Components Digital Radiography (DR) presents a white paper analyzing the clinical benefits of Canon's Intelligent Noise Reduction (Intelligent NR) for pediatric digital radiography.

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